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Per candidarti alla Job incontra dal vivo i selezionatori di Novo Nordisk a ROMA, il 29 ottobre.

A seguito di un’ampia espansione del nostro team e all'entusiasmante periodo di crescita nella nostra Obesity Business Unit, siamo alla ricerca di un ambizioso Key Account Manager da inserire nel nostro team commerciale.

Sei già un Product Specialist o un Key Account Manager di successo? Ti piacerebbe entrare a far parte di una Business Unit impegnata a migliorare la vita di chi lotta contro il sovrappeso patologico e l’obesità?Allora potresti essere la persona giusta. Comincia adesso la tua life changing career in Novo Nordisk!

Il ruolo

In qualità di Key Account Manager (KAM) lavorerai all'interno della Obesity Business Unit per sviluppare il mercato legato alla cura terapeutica dell’eccesso patologico di peso, con un focus sulle regioni della Campania e Puglia.

Inoltre, sarai:

• Responsabile della costruzione e consolidamento di relazioni commerciali sul territorio e dell'attivazione del mercato con farmacie, cliniche private e altri stakeholder commerciali per migliorare l'accessibilità e la continuità terapeutica.
• Responsabile di modellare la domanda di prodotti nei canali commerciali e di creare un ecosistema competitivo che ne sostenga l’adozione e la commercializzazione.
• Responsabile di favorire nuove progettualità che stabiliscano partnership locali fra gli attori della filiera farmaceutica.

Per questo ruolo sono necessarie trasferte regolari all'interno del territorio della Campania e Puglia.

Qualifiche

Il candidato ideale dovrà avere:

• Laurea in materie scientifiche / economiche
• Esperienza minima di 3 anni in aziende operanti nel settore Healthcare con responsabilità commerciali o in società di consulenza
• Esperienza pregressa nel lancio di nuovi prodotti sul mercato
• Esperienza nello sviluppo di solide relazioni con distributori intermedi, responsabili di vendite (CSO), reti di farmacie
• Capacità di sviluppare e implementare strategie commerciali territoriali
• Ottima conoscenza di Excel per la produzione di analisi e forecast
• Buona conoscenza della lingua inglese.

Il Dipartimento

L’Obesity Business Unit si compone di un team dedicato al Marketing, Sales e Commercial. La passione e la determinazione nel migliorare la qualità della vita dei pazienti che vivono con sovrappeso patologico e obesità sono le qualità che ci contraddistinguono.

Per candidarti alla Job incontra dal vivo i selezionatori di Novo Nordisk a ROMA, il 29 ottobre.

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Randstad Italia Specialty Pharma ricerca per azienda leader nel settore farmaceutico un Research Associate - Structural Characterization.

Sede di lavoro: Guidonia Montecelio (RM)

Si offre: contratto di somministrazione iniziale a tempo determinato con possibilità di crescita personale e professionale, e livello da definire sulla base della reale esperienza del candidato.
Orario di lavoro: full time, 38 ore a settimana dal lunedì al venerdì, con mezz'ora di pausa pranzo.

Mansioni:

• conduzione di esperimenti analitici per la caratterizzazione di biologici DS, DP e IPCs;
• interpretazione e analisi dei dati di spettrometria di massa;
• redazione di report scientifici;
• collaborazione con il team di ricerca e con i clienti.

Requisiti richiesti:

• laurea in discipline scientifiche;
• pregressa esperienza di un anno in ruolo analogo o ambiente di laboratorio;
• buona padronanza strumentazione informatica;
• buona conoscenza lingua inglese.

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Randstad Inhouse Specialty Pharma ricerca per strutturata azienda multinazionale un supervisore della produzione, che si occuperà di gestire le linee e le risorse affidate per soddisfare le richieste nei tempi previsti ed in conformità agli standard di sicurezza del lavoro, qualità (GMP) e gestione dei dati (ALCOA).

Sede di lavoro: Catania

Mansioni:

• gestisce, coordina e monitora le attività del personale di reparto, assumendosi la responsabilità di segnalare azioni o comportamenti non in linea con la compliance aziendale o le normative di settore.
• coinvolge il proprio team guidandolo verso il raggiungimento delle aspettative aziendali ed il miglioramento delle loro performance professionali. Restituisce feedback precisi e puntuali sul loro operato e si occupa della valutazione annuale delle loro prestazioni e di individuare eventuali percorsi di formazione dedicati.
• soddisfa gli obiettivi di produzione, organizza e pianifica quanto necessario per le attività lavorative
• stabilisce le priorità e gli obiettivi per turno di lavoro e monitora l’avanzamento delle attività.
• verifica in progress la corretta compilazione dei master Electronic Batch Record (EBR) e della documentazione.
• gestisce tempestivamente l’emissione di deviazioni, prende decisioni e coinvolge le funzioni interessate collaborando affinché la deviazione di compliance osservata venga investigata in accordo alle procedure operative di sito.
• interagisce con le funzioni aziendali (es. Manutenzione, Convalida, Qualità) al fine di garantire il corretto funzionamento delle apparecchiature e il rispetto delle norme GMP.
• apporta continui miglioramenti ai processi di lavoro.
• collabora alla stesura del budget della propria area.

Requisiti richiesti:

• laurea in materie scientifiche (Farmacia, Chimica e Tecnologie Farmaceutiche, Chimica o Ingegneria Chimica);
• ottima padronanza nell’uso del pc e dei principali gestionali aziendali;
• fluente conoscenza della lingua inglese;
• pregressa esperienza in ambito farmaceutico oppure in ruolo analogo o come capoturno;

Spiccate capacità analitiche, organizzative e di orientamento all’obiettivo completano il profilo.

Si offre contratto di somministrazione in ambiente dinamico e stimolante con prospettive personali e professionali. La durata del contratto e l’inquadramento saranno commisurati alla reale esperienza del candidato.

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Randstad Italia spa Specialty Pharma ricerca un addetto agli affari regolatori per un'importante realtà del settore cosmetico.

Sede di lavoro: Crema

Si offre: Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato, si offrono reali ed interessanti opportunità di crescita personale e professionale.

Mansioni:

• archivio documentazione relativa a materie prime in uso;
• valutazione della documentazione e della compliance delle materie prime e delle formulazioni;
• stesura scheda prodotto e di sicurezza tramite software dedicato;
• supporto ai clienti per redazione della documentazione necessaria alla commercializzazione dei prodotti EU ed extra-EU;
• stretta collaborazione con team R&D e marketing;
• monitoraggio aggiornamenti legislativi legati al cosmetico a livello EU ed extra-EU.

Requisiti richiesti:

• laurea magistrale in discipline scientifiche (es. chimica, CTF, farmacia, biologia), gradito master in affari regolatori;
• esperienza pregressa di almeno 6 mesi nella mansione, preferibilmente in azienda cosmetica;
• ottima conoscenza della lingua inglese;
• ottima padronanza dei principali strumenti informatici.

Buone capacità organizzative e di gestione del tempo e spiccate doti di mediazione e collaborazione trasversali completano il profilo.

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Reporting to: Medical Affairs Director
Location: Florence, HQ

CONTEXT
The Medical Affair Team (Italy) has the primary objective to support he scientific information and development on the Menarini products.
The Medical Manager works closely with the Product Manager. Other internal relationships include relations with MSL Lead, Pharmacovigilance and Regulatory personnel. External relationships include MSLs, Medical Reps, Corporate Medical Managers, Scientific Societies,KOLs

MAIN ACTIVITIES AND RESPONSIBILITIES

• Cooperate with Product Manager in developing of the medical component of the brand strategy;
• Develop and execute medical affairs plan for the products;
• Manage clinical trials in cooperation with Corporate Medical Affairs department, in the role of LOCAL Study Medical Expert;
• Develop a proper advocacy plan and engage with national Key Opinion Leader;
• Support MSLs in the execution of the local medical plan;
• Release scientific trainings to medical reps and MSLs;
• Create and review promotional materials;
• Cooperate with other Departments (Regulatory/Market Access/Pharmacovigilance) in the preparation of relevant documents necessary to meet the requirements of local Health Authorities;
• Medical enquiries management;
• Support/investigate life cycle management initiatives for the products.

JOB REQUIREMENTS

• Bachelor's degree in Medicine;
• Specialization in internistic disciplines or pharmacology preferred;
• Fluent English in written and verbal format;
• Optimal use of Microsoft Office (PowerPoint, Excel and Word);
• Communication and public speaking skills;
• Relational and organizational skills;
• Team working skills;
• Up to 30% overnight travel, including abroad required.

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Per candidarti alla Job incontra dal vivo i selezionatori di BSP Pharmaceuticals a ROMA, il 29 ottobre.

We are currently looking for a Technology Transfer Stage - that will mainly ensure:

Main Activities:

• Define the product transfer team, the transfer times, the assignment of responsibilities between the client and the internal company functions, the coordination of activities and management of the budget assigned to the project;
• Ensure the transfer within the site and of the project technical information acquired by the client;
• Be the main interface with the client during the execution of the project activities;
• Ensure the execution of the transfer protocol, the review and approval of the manufacturing instructions of the batches involved in the transfer, the definition and management of the materials involved in the project based on client needs and company needs;
• Supervise the manufacturing of the batches involved in the transfer;
• Support the TT Manager in acquiring the necessary informations for the preparation of contracts with client and in the revisioning after possible changes requested;
• Support the finalization of the new business opportunities definition process, by supporting Business Development during meetings with client.

Requirements:

• Master's Degree in Chemistry, Chemistry and Pharmaceutical Technology, Engineering
• Professional knowledge of English
• Strong analytical skills, business-oriented, client-oriented
• Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP.

 

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Employer: Novo Nordisk Engineering (NNE)

Are you experienced working with Good Manufacturing Practice (GMP) in projects or operations? Would you like to be part of a team of skilled colleagues, ensuring GMP compliance in engineering projects shaping the pharma facilities of the future? And do you thrive on engaging with customers? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg and/or Virum

The Role & Department
We are seeking GMP Consultants to join our GMP Design & Support department. Our team tackles innovative and complex projects that will challenge and engage you. Why do we need you? Our mission is to help our customers bring well-designed GMP facilities into operation quickly and predictably. Your role will be pivotal in delivering the best possible service to our clients, making your broad knowledge and expertise in GMP regulations and compliance essential.

Responsabilities
As a GMP Consultant, you’ll be:

• Supporting our customers in setting the GMP design strategy for engineering projects, and verifying compliance with the strategy throughout the project.
• Facilitating the interpretation of cGMP to ensure that the solutions delivered to our customers are GMP compliant.
• Focusing on customer needs for an innovative and efficient pharma business operation, without compromising GMP compliance.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• Passionate about bringing well-designed GMP facilities into operation.
• Enthusiastic, results-oriented, and have a desire to learn and act as a mentor to others.
• Enjoying variation and flexibility in your projects.
• Demonstrating technical curiosity as well as a sense of quality and service.
• Responsible when solving tasks, and you thrive in a dynamic and global work environment where you can work independently as well as in teams.
• Approaching projects and customers with a can-do attitude, and you can listen and ask questions to understand their needs.
• Understanding and respectful of your colleagues’ individual and cultural differences.

We believe these qualifications are needed for you to do well in this role:

• You have experience working in a GMP-regulated environment.
• You are knowledgeable about GMP regulations and how to apply them in your work.
• You are familiar with terminologies like Quality Risk Management, Room Classifications, and Science and Risk-based approaches to validation
• You value having fruitful dialogues with colleagues and customers.
• You speak and write fluent English.
• You have a diploma or master’s degree in life sciences or other relevant education.

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

Per azienda cliente specializzata nello sviluppo, produzione e commercializzazione di principi attivi farmaceutici (Generici APIs, Citotossici APIs, Peptidi APIs), ricerco

Production & Process Development Officer

Sede: Cinisello Balsamo (MI)

Contratto: iniziale contratto a tempo determinato, CCNL Chimico Farmaceutico, livello di inquadramento e retribuzione in base all’esperienza maturata.

Responsabilità:
Nell’ambito delle attività R&D, su richiesta Supervisore R&D, in accordo con Il Coordinatore di Produzione, supporta sperimentalmente i ricercatori nello svolgimento delle loro attività, sui progetti attivi nell’Unità Peptidi.

• Esegue prove di laboratorio per implementare processi e/o attività di troubleshooting e attività di messa a punto di metodiche analitiche, metodiche di sintesi e di downstream per le fasi di ricerca e sviluppo, operando nel pieno rispetto delle buone regole di laboratorio sulle quali è adeguatamente addestrati.
• Collabora nella stesura ed emissione di Fogli di Lavorazione o Fogli di Bonifica, per processi di prodotti in sviluppo (R&D) o produzioni GMP e di procedure interne.
• Opera nel pieno rispetto delle normative GMP e di sicurezza, sulle quali è adeguatamente addestrati.
• Lavora nei Reparti di Sintesi Chimica e/o Purificazione.
• Conduce in base a metodi di lavoro prestabiliti e in completa autonomia operativa una linea di produzione e/o una tipologia di prodotti.
• Controlla i parametri di funzionamento delle macchine contribuendo alla loro messa a punto e regolazione.
• Garantisce per il corretto smaltimento dei reflui prodotti durante l’esecuzione delle lavorazioni di Reparto.
• Gestisce per le parti di sua competenza e supporta l’attività legata al mantenimento in buono stato di apparecchiature, impianti e strutture dei Reparti di Produzione.
• Garantisce il buon funzionamento e l’aggiornamento della documentazione dei Magazzini Materie Prime, Semilavorati e Finiti Vendita.

Requisiti:

• Laurea chimica industriale, CTF, chimica.
• Buona conoscenza della lingua inglese sufficiente alla gestione delle attività routinarie.

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be responsible for developing our Sourcing of Plastic suppliers to new heights? Do you want to make a difference for patients undergoing surgery by securing the compliance of the medical devices used by healthcare professionals? 

Here you have the opportunity to get an exciting and challenging job, as Principal Category Manager, in a international company. As Ferrosan Medical Devices is growing, you will be able to shape the job in our Strategic Sourcing Department to a large extent. The position refers to the Senior Manager of Strategic Sourcing.

The department Strategic Sourcing is part of Supply Chain Management, which is a central area in Ferrosan Medical Devices. Strategic Sourcing consists of 6 experienced Category Managers covering direct spend, CMOs and Indirect spend including equipment and machinery. The team is responsible for all aspects of supplier management including supplier selection, negotiation, and collaboration as well as risk mitigation, spend/savings program, and category strategies. 

Responsibilities
You get a central position, with responsibility for the collaboration and development of the company's Plastic Suppliers. There will be a great deal of contact with the suppliers, who are primarily in Europe, as well as a broad contact surface across Ferrosan Medical Devices. Your main tasks will be:

• Establishment and maintenance of Category strategies.
• Daily handling and collaboration with our current Suppliers.
• Negotiations and conclusion of contracts. 
• Development of the supplier base.
• Optimizing the processes and structure around the Suppliers.
• Participate in various product development and optimization projects. 

The overall purpose of the position is to ensure robust cooperation and management of our Plastic suppliers, this to reduce total costs through close cooperation, taking quality, reliability and risk management into account.

To be successful, you must internally work closely together with e.g. Finance, the Development department, the Quality organization and your colleagues in Supply Chain Management and Operations.

Your profile
The ideal candidate for the job holds experience from a similar role managing and leading Categories from a highly regulated industry such as medical devices, pharma, biotech, life science or similar. As a person you have a pragmatic approach, and you find solutions to identified problems:

• Minimum B.Sc. – ideally a degree at M.Sc. level as an Engineer, Economist or within Supply Chain.
• Minimum +5 years of experience within purchasing and/or Supply Chain.
• You have experience with Category Management and supplier handling.
• Demonstrated track record in finding pragmatic solutions to complex or challenging problems.
• Highly experienced in stakeholder management.
• Your work style is involving and impactful.
• You think in holistic terms and with a business-oriented approach to the solutions.
• You have created visible results in your current or previous roles.
• You have experience with GMP.
• Possess strong oral/written communication skills in English.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 
 

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Place of work: Pisa (hybrid work)

Type of contract: permanent employment

What will you deal with?

• Prepare the strategy, the technical documentation, perform the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements.
• Give support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.
• Manages the regulatory procedures in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client.

What are the requirements?

• Degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
• At least 1 year of experience in similar roles.
• Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
• Ability to work in a team and aptitude for learning.

What we offer?

• Dynamic and challenging work environment with international projects.
• Ongoing training and opportunities for professional growth.

 

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Per la società ADMENTA Italia, facente parte del gruppo PHOENIX PHARMA ITALIA, siamo alla ricerca di un Farmacista guidato dalla passione che abbia voglia di mettersi in gioco e intraprendere un percorso di crescita all’interno delle nostre Farmacie a marchio Benu.

La risorsa verrà inserita all’interno di un Team di Farmacia e, con il supporto del Responsabile e dei colleghi collaboratori, avrà la possibilità di conoscere a 360° la gestione della Farmacia ad insegna Benu. La risorsa avrà la possibilità di approfondire le sue conoscenze sia on the job sia attraverso corsi di formazione/workshop in diversi ambiti, tra cui omeopatia, fitoterapia e dermocosmesi.

Le attività

• consiglio e vendita alla Clientela
• vendita di farmaci, parafarmaci e prodotti dermocosmetici
• erogazione di servizi quali misurazione pressione, glicemia, colesterolo, peso, vitamina D; analisi capello, pelle, cellulite; analisi intolleranze alimentari; test disbiosi
• sistemazione merce, attività di back office

I requisiti

• Laurea Magistrale a ciclo unico in CTF o Farmacia
• Abilitazione all’esercizio della professione
• Iscrizione all’Ordine
• Capacità di ascolto, empatia e sentirsi parte di una squadra

I benefits

• Ticket buoni pasto
• Premi incentivanti
• Supporto alloggio in caso di trasferimento
• Sconto dipendente su acquisti max 900,00 € di risparmio totale annuo
• Bonus Nascita Figlio
• Bonus Asilo Nido
• Permessi Retribuiti attività Volontariato
• Part-time post maternità
• Assicurazione Evento Rapina Massimale 350.000,00 €
• Conversione festività 4 novembre in permessi
• Permessi di Studio Aggiuntivi
• Previdenza complementare
• Percorsi di formazione on the job e incontri di formazione dedicata alle procedure e policy aziendali (individuali o di gruppo)

 

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In partnership con prestigiosa azienda che produce e commercializza make-up e cosmesi skincare a livello globale, eccellenza del made in Italy, offriamo due interessanti e stimolanti opportunità in ambito Affari Regolatori.

REGULATORY AFFAIRS – settore COSMETICO: junior e senior

Sede di lavoro: CREMA
Contratto offerto: Contratto a tempo indeterminato, CCNL Chimico Farmaceutico.

Principali attività:

• garantire conformità di prodotto e semilavorato rispetto alle normative europee ed extra-europee
• gestire la documentazione tecnica per autorità regolatorie e clienti e monitorare i relativi aggiornamenti
• redigere ed aggiornare i documenti di registrazione in collaborazione con i principali riferimenti interni in ambito Sales & Marketing, Qualità, R&D, Produzione, Logistica
• verificare le specifiche normative per i paesi UE, Extra UE e UK per definire le corrette procedure di spedizione in presenza della documentazione corretta
• gestire direttamente eventuali problematiche con la dogana

Requisiti:

• scolarità scientifica / legale o percorso di studi specifico per il ruolo.
• solida esperienza effettuata in medesimo ruolo e presso aziende appartenenti al settore cosmetico.
• È richiesta buona conoscenza delle normative specifiche che regolano il settore (MDR 2017/745, MDD, MDSAP) della gestione diretta di Audit e autonomia di utilizzo della lingua inglese.
• Ottime capacità comunicative e relazionali per un’ottimale collaborazione con colleghi, enti, clienti e con il team di riferimento, capacità organizzative e predisposizione al problem solving completano il profilo.

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RandstadInHouse  Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for a QC Technician.

Location: Pomezia (RM)

We offer: Level and salary will be adjusted according to the candidate's experience. 

Responsabilities:

• Carry out chemical-physical tests on finished products and raw materials in accordance with GMP standards.
• Finished product control and management of production documentation.
• Specific control of raw materials.
• Carry out analysis on the finished cosmetic products and medical devices.
• Support stability and validation testing on cosmetic and medical device products.

Requirements:

• Five-year scientific degree.
• Good management of the main laboratory instruments (HPLC, GC, IR, UV…).
• Knowledge of ISO standards (9001 and 13485).
• Professional experience: at least 2 years in the Q&C department.

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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partnership con una tra le migliori aziende cosmetiche italiane del make-up e skincare, eccellenza del made in Italy, offriamo un'interessante e stimolante opportunità:

Internship in qualità e packaging cosmetico

Sede: provincia di Bergamo

Contratto: stage di 6 mesi, retribuzione 800 euro al mese, mensa, scopo assunzione. In caso di esperienza pregressa, si valuta inserimento in apprendistato.
Orario di lavoro: 8:00-16:30 con flessibilità fino a 9:15-17:45

Responsabilità:

• Analisi e procedure finalizzate a garantire la compatibilità con il packaging.
• stendere report su rapporti di compatibilità.
• fornire informazioni al marketing.
• omologazione del packaging.
• corretta compilazione della documentazione.

Requisiti richiesti:

• Laurea in ambito scientifico.
• Preferibile esperienza pregressa (anche stage).
• Buona conoscenza della lingua inglese.
• Passione per la cosmesi. 

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Randstad In House Specialty Pharma ricerca per importante azienda cliente un operatore farmaceutico per l’area sperlatura. 

Sede di lavoro: Modugno (BA)

Si offre: contratto in somministrazione di 3 mesi con possibilità di proroghe ed opportunità future di crescita personale e professionale.
CCNL Chimico Industria livello E3.

Mansioni:

• sperlatura dei prodotti iniettabili secondo quanto previsto dal Batch Record e dalle SOP vigenti;
• controllo visivo e controllo qualità sul prodotto finito;
• compilazione batch record e documentazione di reparto.

Requisiti richiesti:

• laurea in Biologia, Chimica, CTF o affini;
• esperienza pregressa in ruolo analogo, oppure contesti farmaceutici produttivi o di laboratorio;
• buona padronanza della Lingua Inglese;
• disponibilità a lavorare su tre turni (6/14, 14/22, 22/6) dal lunedì alla Domenica, con giornate di riposo compensativo.

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Randstad Italia spa, specialty pharma, ricerca per strutturata azienda multinazionale un tecnico di Laboratorio Microbiologico.

Sede di lavoro: Latina

Mansioni:

• effettuare le analisi microbiologiche, delle acque e dei vapori
• condurre i test di sterilità sui campioni dei prodotti,
• eseguire l’analisi del Bioburden sui prodotti al fine di valutare i livelli di contaminazione

in conformità ai protocolli ed agli standard di qualità aziendali.

Requisiti richiesti:

• laurea in discipline scientifiche quali Biologia o Biotecnologie.
• esperienza di almeno 6 mesi in ruolo analogo,
• abilità nell'uso della strumentazione di laboratorio,
• Completano il profilo l’attitudine alla precisione ed all'accuratezza dei risultati e la capacità di lavorare in team e di comunicare efficacemente.

Modalità di lavoro: onsite, con disponibilità al lavoro su 3 turni (6/14, 14/22, 14/22) dal Lunedì alla Domenica con giorni di riposo compensativo.

Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato, si offrono reali ed interessanti opportunità di crescita personale e professionale.

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Array ( [id] => 1291 [azienda_id] => 172 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1729597113 [title] => Site Activation Specialist [body] =>

Siamo sempre alla ricerca di talenti! Anche se al momento non abbiamo posizioni aperte, ti invitiamo a inviare il tuo CV! I candidati verranno considerati per future opportunità che si apriranno a breve. Grazie per il tuo interesse!

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.

Job responsabilities:

• General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. 

Responsible for one or more of the following functions at the country level:

• Local Submissions Specialist - Follows the project direction provided by the designated country startup advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during startup on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.
• Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution.
• Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

What we’re looking for:

• Associate’s Degree or equivalent combination of education and training.
• Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Good English skills.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.

Siamo sempre alla ricerca di talenti! Anche se al momento non abbiamo posizioni aperte, ti invitiamo a inviare il tuo CV! I candidati verranno considerati per future opportunità che si apriranno a breve. Grazie per il tuo interesse!

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Randstad Italia Specialty Pharma, per strutturata azienda farmaceutica, ricerca un Validation Specialist

Sede di lavoro: Pomezia (RM)
Orario di lavoro: full time giornaliero da lunedì a venerdì

Mansioni:

• redazione e compilazione della documentazione di reparto, relativa alle attività diqualifica/riqualifica (ad es. protocolli di qualifica/riqualifica, risk assessment, procedure operative standard ecc.);
• esecuzione delle attività di qualifica/riqualifica di impianti e macchine farmaceutiche;
• analisi dei risultati ottenuti durante l’esecuzione dei test di qualifica per verificare il rispetto dei criteri d’accettazione stabiliti e, in presenza di problematiche, collaborazione alla risoluzione delle stesse e partecipazione alla definizione delle azioni correttive da intraprendere, dopo la condivisione con il proprio responsabile.
• esecuzione dellle attività di qualifica (IQ, OQ, PQ) e di riqualifica (RQ) di equipment, sistemi, impianti (es. autoclave, HVAC, tunnel di depirogenazione, loop WFI) garantendo il rispetto delle tempistiche stabilite, operando secondo le modalità
• riportate nei documenti di riferimento approvati.

Requisiti richiesti

• laurea in discipline scientifiche;
• esperienza nella mansione di almeno 3 anni;
• fluente conoscenza della lingua inglese;
• la buona conoscenza della CSV (Computer System Validation) e l’esperienza di lavoro presso aziende farmaceutiche dotate di camere sterili per prodotti iniettabili costituirà titolo preferenziale;
• Completano il profilo doti di precisione e la capacità di lavorare in team;

 

Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato, si offrono reali ed interessanti opportunità di crescita personale e professionale.

 

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Employer: GENMAB

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
Genmab is searching for an experienced Clinical Drug Supply Manager to be part of Global Clinical Drug Supply Operations in Copenhagen, DK or Princeton, NJ in commuting distance to our office locations to work according to our hybrid work arrangement.

Moving forward with many late-stage trials in pipeline, the Clinical Drug Supply Manager will be managing outsourcing of packaging, labelling, and distribution of clinical trial supplies for early as well as late stage Genmab clinical trials. The Clinical Drug Supply Manager will work closely with GMP QA and our CMOs ensuring timely packaging and labelling for our clinical trials as well as IST and PAA for patients with cancer and other serious diseases.

The Clinical Drug Supply Manager must have extensive knowledge of cGMP and have a focus on the level of quality in work performed.

The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen.

Responsibilities

• Manage and coordinate drug supply and to provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
• Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
• Set-up English Master Label, manage label translation without vendor and approval of label proofs/designs.
• Manage set-up of distribution framework through service providers.
• Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
• Contribute to maintenance of SOPs and Work Instructions in the department.
• Perform training of other team members.
• Function as Subject Matter Expert within relevant areas.
• Responsible for being compliant with Genmab’s quality system.

Requirements

• At least 3 years’ experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
• Ability to manage stakeholders internally and externally.
• Experience working with CMO for clinical trial supplies.
• Training in GDP, GMP and GCP is a requirement.
• Experience working with IST and PAA from a Sponsor perspective will be an advantage.
• Excellent communication skills in English - both oral and written.

Moreover, you meet the following Personal Requirements

• You can structure and organize your work.
• You are process oriented and contribute to continuous improvements.
• You have a quality mindset and can prioritize your work in a fast paced and changing environment.
• You have good interpersonal and communication skills.
• You can work independently as well as within global teams.
• You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

The Team
You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs.
Together with Global Clinical Drug Supply Systems team the three teams make up the Global Clinical Drug Supply department.
We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.

 

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Employer: Aarhus University

The Department of Biomedicine at Faculty of Health at Aarhus University invites applications for a position as a laboratory technologist within biochemistry, medical biology and translational research as per 1 January 2025 or as soon as possible thereafter. The position is a permanent full-time position.

The Department of Biomedicine prioritises diversity and a good work environment, as this is a prerequisite for groundbreaking research. In a diverse and international research environment, dedicated employees are looking to generate new knowledge within biomedical research areas such as infection and inflammation, membranes, neuroscience and personalised medicine. The Department of Biomedicine provides research-based teaching of the highest quality and is responsible for a large part of the medical degree programme. Academic staff contribute to the teaching. English is the preferred language in the laboratory, at meetings and at seminars. The department employs approx. 500 people from all over the world, and they make use of the department's modern laboratory-, core- and animal facilities. The Department of Biomedicine focuses on innovation, entrepreneurship and collaboration with business and industry, and numerous researchers from the department have established companies to develop new medicinal treatments founded in professional scientific basic research. 

Responsibilities
As laboratory technologist, your primary tasks consist in performing multiple biochemical analyses as well as managing samples storage and preparation. You contribute also to the general laboratory operation of the team and the operational and maintenance of laboratory equipment. In your daily work, you have a close interaction with competent colleagues in a stimulating environment.

Your main tasks will consist of:

• Collection, storage, and preparation of samples from mouse and human origine
• DNA, RNA, and protein extraction
• Measure of genes and proteins expression (PCR, Western blotting)
• Operation and maintenance of laboratory equipment
• Management of laboratory consumable and procurement

You will report to group leader, Professor Frederic Gachon.

Requirements

• You have a background as Laboratory technologist (laborant) or Medical Laboratory Technologist (bioanalytiker).
• Experience and training in animal experimentation.
• The work language will be English and a reasonable level of understanding, writing, and speaking in English is required.
• You have good interpersonal skills.
• Inclusive and team-oriented and able to contribute to a good work environment.

Terms of employment
Terms of employment and pay are regulated by the collective agreement between the Ministry of Taxation and the Organisations of Public Employees, Denmark (OAO) or the Danish Confederation of Public Employees of 2010 (LC/CO10).

 

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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale.

 Per azienda cliente che produce nella Cosmetic Valley lombarda linee complete di make-up per i grandi marchi internazionali, ricerchiamo:

Addetto/a al Controllo Qualità analitico e documentale

I prodotti di cui ti occuperai sono: skincare, body care, baby care, fotoprotezione e profumi.

Sede: provincia di Monza e Brianza

Contratto: assunzione diretta a tempo indeterminato, CCNL Chimico.
Remote working: 2 giorni a settimana.

Inserimento previsto entro novembre 2024.

Responsabilità:

• Controllare materie prime, semi-lavorati e qualsiasi componente del processo produttivo compreso il prodotto finito.
• Rilevare e segnalare difetti di standard.
• Proporre idee per migliorare il livello qualitativo o eliminare eventuali difetti rilevati.
• Pianificare e svolgere i controlli d'ispezione.
• Scegliere i campioni da ispezionare o da testare.
• Testare parametri di analisi con strumentazione di laboratorio.
• Interfacciarsi con laboratori esterni per le analisi microbiologiche  Preparare i certificati di qualità.
• Tenere traccia dei difetti riscontrati, conservare e aggiornare la documentazione e le schede tecniche  Restare in continuo aggiornamento su protocolli, tecniche e norme.

Requisiti:

• Esperienza di 1 anno nel ruolo.
• Buone capacità comunicative, spirito collaborativo, organizzazione e attenzione al dettaglio.

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Employer: Demant

Do you want to start your career with a job that really makes a difference? 

The Graduate Programme at Demant offers you a unique opportunity to develop your personal and professional skills in a great working environment. You will join us in improving the lives of millions of people worldwide through hearing health.

We offer 10 different tracks:

1. Commercial Excellence
2. Global Business
3. Intellectual Properties
4. Operations
5. Finance
6. Tax
7. Audiology
8. Legal 
9. Engineering 
10. Commercial 

How it works?
Each track will take you through three or four rotations in a two-year journey. During your rotations, you will get hands-on experience with different challenging projects that allow you to learn and build on your knowledge and skills. We are a global company, so all tracks are designed with an international perspective, in fact, many of our graduates also have the opportunity to go abroad for one rotation. 

After successfully completing the Programme, we offer you a permanent position with Demant - either in Denmark or abroad. However during the Graduate Programme graduates receive a full-time salary from the start.

As a graduate, you will have an introduction week in the beginning, training bootcamps, visits to our business sites, as well as management meetings. Also, we offer you a beneficial health insurance, a wide range of sporting and leisure clubs including offer for massages, a healthy and delicious canteen, and lot of fun activities and events with the other graduates.

When does the Graduate Program start?
The recruitment window will open from 1^st of November 2024, the Programme will start on 1^st September 2025.

For foreign students:
Demant is an international company, and our business language is English. It is possible to apply for the Graduate Programme before you graduate, as long as you complete your studies before the start of the Programme.

Further information: 
https://www.demant.com/jobs-and-career/graduate-programme

⚠️ To submit your application, please go to the following site:
https://www.demant.com/jobs-and-career/graduate-programme

 

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Employer: Novo Nordisk Engineering (NNE)

Does the idea of learning about Process Control Systems excite you? And do you thrive in gaining knowledge of GMP and pharmaceutical production? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg

The Role & Department
We are looking for newly graduated Automation Engineers to join our team of Process Automation Engineers. As a team, we are working on the biggest projects in Novo Nordisk history. Our goal is to implement robust and future-proof solutions for our customers. Your role will be key in designing, implementing, and validating automation solutions for the pharmaceutical industries.

Responsabilities

• Designing, developing, implementing, qualifying, and supporting Process Control Systems /Distributed control system (DCS).
• Interacting with process experts and colleagues with expertise in surrounding systems and equipment like Manufacturing Execution System (MES), Historian systems, Instruments, Production equipment etc.
• Developing and optimizing automation methods and strategies to meet our customers’ challenges and sharing state-of-the-art knowledge with colleagues and partners.
• Advising customers on their selection of automation solutions.
• Forming the basis of automation strategies and architectures to support our sister departments internationally and expand NNE’s Process Automation engagement.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• A team-oriented person, curious and eager to learn.
• Comfortable with customer relations.
• Passionate about your work and with a personal drive.
• Pro-active, cooperative and with a motivated mindset.

We believe these qualifications are needed for you to do well in this role:

• You have a degree within chemistry, automation, or electrical engineering.
• You have an interest of working with PCS/DCS Application development such as ABB 800xA or ABB SattLine).
• You find the GMP/GAMP environment exciting.

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Employer: Ferrosan Medical Devices

Introduction 
Do you want to be a part of Technical Support in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills. Every 2nd second, Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!  

Manufacturing at Ferrosan Medical Devices
Manufacturing in Ferrosan Medical Devices consists of approximately 190 people spread across key departments – two production departments, Process Support, EHS and Technical Support, Utility & Facility. These departments work cohesively to ensure the seamless production and delivery of our cutting-edge medical devices, demonstrating a commitment to precision, efficiency, and continuous improvement adhering to Lean methodologies. This position is organized in the “Technical Support, Utility & Facility team” which consists of 24 engineers and technical staff with different technical backgrounds and is led by a Senior Manager and a Manager. You will mainly work together with two other facility colleagues.

Position Overview
Ferrosan Medical Devices is currently investing many resources in their headquarter site in Søborg. So far this has resulted in building a state-of-the-art new factory and updating the utilities, so that daily operations continue to be both energy-efficient and compliant with regulations. Furthermore, the ambition for the Automation area is to become even more robust and thereby more process-oriented through updated system descriptions and renewed processes.

As a result of the investments and renewed ambitions, Ferrosan Medical Devices is now looking to strengthen their department for Technical Support & Utilities by hiring an Automation Engineer, who can help take responsibility for the automated systems used in the manufacturing operations. Your new team consists of 24 highly skilled colleagues who enjoy helping each other and sharing their knowledge.

Your role
As Automation Engineer you will be supporting the Technical Support team with your automation knowledge, and you get to participate in various optimizing projects of production and utility systems to ensure continuous optimization of the technical equipment and machines including setting requirements, testing and documentation. Further you be participating in troubleshooting together with utilities technicians in our production facilities and utilities installations including ensuring the right electrical drawings and machine/system documentation.

During operationally critical situations you provide support to onsite technicians and process owners.

Further tasks could include:

• Updating electrical documentation
• Back-up of parameters in VLT/frequency converters, PLCs
• Troubleshooting and service tasks on existing systems
• Development tasks in collaboration with colleagues and vendors.
• Participating in Testing and (re)commissioning of production machines and utility systems.
• Handling compliance documentation and deviations.

Your profile
First and foremost, it is vital that you are a true team player and a great colleague. You have relevant technical skills, preferably supplemented with experience in automation and GMP production.

• You have experience with PLC - preferably Siemens software S5, S7, TIA
• You can read Siemens PLC code
• Troubleshoot system PLC controller by using PLC code documents.
• Have a good knowledge of frequency inverters e.g. Danfoss
• Have good knowledge of machines safety, with various levels of protection
• Have a good knowledge of automations div. instruments, signals, measuring principles etc.
• Can read electrical wiring diagrams and use them for troubleshooting
• Have good knowledge of working within GMP area and compliance.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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Sei un biologo, un chimico o hai una laurea in CTF?
Vuoi fare la differenza nel settore farmaceutico, alimentare o in altri ambiti strategici?

Il Master Quality di Uninform Group – giunto alla 87ª Edizione – ti offre una formazione completa e approfondita nei sistemi di gestione aziendale, con focus su qualità, ambiente, sicurezza e agroalimentare, permettendoti di acquisire competenze e titoli altamente richiesti dal mercato del lavoro e di contribuire all'innovazione e alla sostenibilità delle aziende.

Iscriviti ora e diventa un professionista del futuro!

Date, modalità di frequenza e numeri del Master:
La prossima Edizione inizierà il 23/10/2024, l’Edizione successiva inizierà a febbraio 2025 (ogni anno si prevedono 3 Edizioni a febbraio, maggio, ottobre).

Il Master Quality si svolgerà con frequenza full time, dal lunedì al venerdì dalle 09:00 alle 18:00, in modalità E-Learning oppure a Roma o Milano.

-2 mesi di fase d’aula con un piano di Studi completo e trasversale e con docenti professionisti del settore.
-6 mesi di stage garantito presso una delle oltre 750 aziende partner, tra le più importanti in tutti i settori dell’economia, ed in particolare in ambiti alimentare, farmaceutico, biomedico, consulenziale, aerospaziale, e molti altri.
-15 Attestati qualificati CEPAS, compresi i Lead Auditor in Qualità, Sicurezza, Ambiente, Energia e Agroalimentare, pronti ad essere spesi anche in contesti internazionali.
-92% di Placement Occupazionale, testimoniato dalle storie di successo nelle precedenti 86 edizioni con oltre 3.500 ex Allievi oggi assunti nelle più importanti aziende in tutti i settori dell’economia.
-Sbocchi Professionali: Responsabile/Auditor Qualità, Auditor Ambientale, Ecomanager, Esperto di Impatto Ambientale, Ispettore presso Enti di Certificazione, Consulente Sistemi di Gestione Aziendale, Responsabile Sicurezza RSPP, HSE Manager ed altre figure professionali in linea con il settore.

Per iscriversi:
Per iscriversi al Master è necessario prenotare sul sito di Uninform Group la selezione di accesso che consiste in un colloquio conoscitivo/motivazionale in video call Skype e nella valutazione, da parte dell’ufficio placement, del curriculum del candidato, degli studi effettuati ed eventuali esperienze svolte.

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Employer: Novo Nordisk - Denmark

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Locations: We are looking for candidates to all our locations. This specific pipeline covers on-site positions in Kalundborg.

The Role & Department
Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Are you driven by automation and digitalization of the Novo Nordisk manufacturing value chain? Look no further!
We are building a talent pipeline for Junior Professionals to join Novo Nordisk in shaping the future through automation.

Joining the Automation Engineers Pipeline

By applying for the pipeline, you will be considered as a potential match for on-site automation related positions, which align with your background, skills, and interests across various areas in Denmark.

 

Due to the expansion of our activities in all business areas and sites, we are currently seeking talents for many different teams across Novo Nordisk, such as Advanced automation, Manufacturing Execution Systems (MES), and Collaborative- and industrial robotics. We encourage you to read more detailed information about the different roles and areas through this link: https://www.novonordisk.com/careers/campaigns/automation-engineer-process-digitalization.html

Requirements
We are looking for someone with an innovative and solution-oriented mindset. As you will be working and collaborating with people from various departments in the organization, it would be preferable that you are ready to take the lead on deploying solutions that bring value.

To apply to our pipeline, we expect that you:

• Are newly graduated with a bachelor’s or master’s degree within e.g., IT, Automation, or Robotics
• Would like to build on your skills and experience together with highly dedicated colleagues.
• Are proactive, solution-oriented, like to share your knowledge and collaborate effectively.
• Work systematically and with the ability to develop and implement practical actions to deal with issues.
• Have proficient oral and written communications skills in English. Danish language skills are great advantage.
• As documentation according to Good Manufacturing Practice (GMP), rules are part of our daily work, it is important that you thrive in ensuring that all your work is well documented.

 

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Siamo sempre alla ricerca di talenti! Anche se al momento non abbiamo posizioni aperte, ti invitiamo a inviare il tuo CV! I candidati verranno considerati per future opportunità che si apriranno a breve. Grazie per il tuo interesse!

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Contract: Permanent

Job summary:
Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Job responsabilities:

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. 
• Supports the SSUL to agree on country template contract and budget. Assists in producing site-specific contracts from country template.
• Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SSUL lead with Sponsor until resolution of issues. 
• Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Assists SSU leads, Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
• Facilitates the execution of contracts by company signatories.
• Supports the maintenance of contract templates and site specific files and databases.
• Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary. 
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

What we’re looking for:

• BA/BS degree in related field or equivalent combination of education and experience.
• Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred.
• Strong skills in Microsoft Office Suite, email, and voicemail.
• Strong organizational, presentation, documentation, and interpersonal skills.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel.
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Ability to take direction from multiple individuals and set priorities accordingly.
• Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
• Demonstrated ability to work independently, as well as part of a team.
• Utilize problem-solving techniques effectively.
• Quality-driven in all managed activities.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
• Strong computer skills, including Word, Excel.

Siamo sempre alla ricerca di talenti! Anche se al momento non abbiamo posizioni aperte, ti invitiamo a inviare il tuo CV! I candidati verranno considerati per future opportunità che si apriranno a breve. Grazie per il tuo interesse!

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Ruolo: CSV Intern

Sede: L’Aquila (AQ), con disponibilità a viaggiare su tutto il Territorio Nazionale secondo le necessità di progetto per il raggiungimento degli stabilimenti dei clienti.
Contratto: iniziale stage extracurriculare, finalizzato ad assunzione in apprendistato.
Orario di lavoro: full time

Disponibilità: Immediata

S4BT è un’Azienda di oltre 80 specialisti e specialiste, che da quasi 30 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo, in diversi ambiti come qualità, ingegneria, Project
Management, Validazioni, Tech Transfer, Computer System Validation e altro.
Proprio per l’area Computer System Validation, ricerchiamo un profilo neolaureato che, grazie al supporto di un tutor, intraprenderà un percorso formativo tale da ricoprire il ruolo di CSV Intern.

Come CSV Intern, di cosa ti occuperai?

♦︎ Avrai l’opportunità di intraprendere un percorso formativo che ti permetterà di eseguire attività di progetto in ambito Computer System Validation (redazione di documenti ed esecuzione in campo di protocolli di test, per la convalida dei sistemi computerizzati utilizzati in ambito GxP) in termini di:

• Partecipazione a corsi di formazioni erogati all’interno dell’azienda.
• Affiancamento nei progetti assegnati.

♦︎ Parteciperai a meeting di condivisione di progetto e di area con tutto il team CSV.

Cosa ci piace in un/a candidato/a?

• Un/a vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro.
• L’attitudine a far proprie le linee guida aziendali.
• La curiosità, l’entusiasmo e l’energia.
• La partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Cosa richiediamo?

• Laurea triennale o magistrale in discipline tecnico-ingegneristiche e chimico-farmaceutiche.
• Interesse e curiosità nella convalida di sistemi computerizzati ed infrastrutture di rete.
• Interesse e curiosità in ambito Quality Assurance and Compliance.
• Buona conoscenza della lingua Inglese sia scritta che parlata (livello minimo B1).
• Buona conoscenza del pacchetto Office.

Se ti interessa la posizione vieni a conoscerci a Roma, il 29 ottobre 2024!

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Randstad InHouse Specialty Pharma ricerca per un'importante azienda multinazionale del settore chimico farmaceutico un analista di laboratorio chimico. la risorsa entrerà a far parte del team controllo qualità.

Sede di lavoro: provincia di Frosinone

Si offre: Si offre contratto in somministrazione ed opportunità future di crescita personale e professionale.
Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato.

Mansioni:

• test su materie prime, semilavorati e prodotti finiti;
• eseguire prove fisiche (pH, KF, Osmolalità), cromatografiche (HPLC/UPLC) ed analisi biochimiche (RT-PCR, SDS-Page, Sanger Sequencing, cIEF, Dot-Blot);
• effettuare studi di stabilità e rilascio;
• garantire l'esecuzione della validazione e del trasferimento dei metodi analitici;
• compilare la documentazione relativa alle attività secondo le norme GMP.

Requisiti richiesti:

• laurea in Farmacia, CTF, Chimica o in discipline scientifiche;
• buona comprensione della lingua inglese;
• esperienza pregressa in ruolo e contesto analogo di almeno un anno;
• disponibilità al lavoro a giornata e su 3 turni (6/14, 14/22, 22/6) dal lunedì alla Domenica con riposi compensativi.

L’attenzione ai dettagli, la capacità di concentrazione e l’orientamento al risultato completano il profilo.

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Employer: Novo Nordisk Engineering (NNE)

Do you want to work with a highly skilled project team in a complex setting, and does the idea of making an impact for patients all over the world excite you? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg

The Role & Department
We are looking to expand our team of almost 50 highly skilled, cross-disciplinary project managers. We are currently leading some of the most exciting and interesting engineering projects within pharma and biotech projects. All activities are project-based, and you will be playing a key role in a successful delivery.

Your role in the project will be either as a work package owner with responsibility for one or several work packages or as an assisting PM to one of our more senior project managers.

Responsabilities
As Project Manager, you’ll be with a multi-disciplinary team, where you’ll be:

• Taking leadership to ensure project objectives are met within scope, budget, and timeline.
• Developing and maintaining detailed project plans, including milestones, resources, and risk management.
• Serving as a key liaison between clients, stakeholders, and internal teams to facilitate communication and ensure project alignment with organizational goals.
• Motivate and inspire the project team.
• Identifying potential risks and implementing proactive strategies to mitigate challenges.
• Supporting the continuous improvement of project management processes within the organization.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• understanding of your colleagues’ individual and cultural differences.
• a good listener who always comes with solutions.
• aware of your surroundings and able to flag any concerns.
• agile and able to prioritize urgent tasks.
• able to collaborate on team projects.
• excited to build on the NNE culture of innovation.

In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role:

• You have a M.Sc. or B.Sc. within engineering, chemistry, biotechnology, pharmaceutical production or similar
• You have proven project management skills.
• You communicate well in English, both in writing and orally.
• Familiarity with the pharmaceutical and biotech industries is an advantage.
• If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Randstad Italia, specialty pharma, per azienda farmaceutica specializzata nella produzione di liquidi sterili iniettabili, ricerca operatori di camera sterile.

Sede di lavoro: Latina
Orario di lavoro: su 3 turni (6/14, 14/22, 14/22) dal Lunedì alla Domenica con giorni di riposo compensativo.

Mansioni:

• effettuare la dissoluzione e filtrazione dei prodotti farmaceutici, ed i lavaggi e la sterilizzazione dei serbatoi di produzione;
• caricare e scaricare il liostato;
• eseguire le verifiche periodiche di corretta funzionalità delle apparecchiature comunicando in modo tempestivo al superiore eventuali anomalie;
• compilare il batch record e la documentazione di reparto;

Requisiti richiesti:

• diploma di scuola superiore preferibilmente ad indirizzo tecnico;
• precedente esperienza di almeno 6 mesi come operatore di camera sterile presso aziende farmaceutiche
• conoscenza sop e gmp;
• Completano il profilo caratteristiche personali di serietà, attenzione e capacità di operare nel rispetto dei ruoli.

Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato, si offrono reali ed interessanti opportunità di crescita personale e professionale.

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With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock
exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe
who we serve. We develop and commercialize medicines to serve people living with common diseases, as well as those living with some of the rarest, in around
150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for
common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.

Job purpose:

The resource, integrated into the Marketing team of the Specialty and Primary Care division, will be supported in a targeted professional growth path aimed
at understanding the role and activities of the Product Manager.

Key responsibilities:

• Support the design and creation of promotional materials for pharmaceutical products.
• Collaborate with the marketing team to develop persuasive and informative content.
• Ensure regulatory compliance and information accuracy in promotional materials through interaction with the Medical Department and Regulatory Affairs.
• Support the Product Manager in the management and implementation of specific projects.
• Contribute to defining project objectives and planning activities.
• Coordinate with various departments to ensure effective collaboration in project implementation.
• Collect and analyze market data to identify trends, opportunities, and threats.
• Contribute to the evaluation of product performance based on sales metrics and market research.
• Collaborate with sales representatives and other stakeholders to gather field feedback and adapt marketing strategies accordingly.
• Participate in meetings and presentations to effectively communicate product-related information.
• Participate in internal training programs to acquire specific pharmaceutical industry skills.
• Maintain updated knowledge of industry regulations and guidelines.

Required skills, qualifications, experience and behaviours:

• High level of proficiency with Office Suite (MS Word, MS Excel, MS PowerPoint).
• Analytical and goal oriented
• Excellent communication skills
• Desire to work in cross functional team with a result driven approach.
• Flexibility, proactiveness, goal-oriented approach, and a marketing-oriented mindset will be considered preferential attributes

Education (minimum/ preferable): Degree in Scientific disciplines
Languages and level: English – B2 both written and spoken
Previous internship experiences or abroad experiences will be considered as a plus

 

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and
cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and
develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender
identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

 

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Il corso in breve
Il corso Missione CRA è un corso online formulato per chi desidera diventare professionista nel settore della ricerca clinica. Cinquanta ore di formazione e contenuti extra per conoscere questa realtà professionale e scoprire quali sono le mansioni del Clinical Research Associate e degli altri attori coinvolti. Trainer esperti, che lavorano ogni giorno della ricerca, condividono la propria esperienza attraverso attività pratiche, project work e confronto diretto durante le lezioni live. Ogni lezione è online e viene registrata affinché si possa rivedere e recuperare sulla piattaforma e-learning.

Al termine del percorso formativo:

• avrai compreso i principi delle Good Clinical Practice (GCP);
• avrai colto i meccanismi che governano lo sviluppo di un nuovo farmaco in un contesto regolato da normative italiane e regolamenti europei;
• saprai cosa è la Farmacovigilanza e come si gestiscono gli eventi avversi;
• sarai consapevole di quelle che sono le principali sfide e le grandi opportunità del mondo della Ricerca Clinica;
• avrai completato le ore formative richieste dal DM 15/11/2011.

Oltre ad una formazione specifica sulla ricerca clinica, durante il corso Missione CRA viene fornita assistenza e supporto nella ricerca attiva del lavoro, attraverso la revisione dei curricula, lezioni di coaching e accesso ad un canale riservato con i diversi annunci di lavoro.

Prossima edizione
La prossima edizione avrà inizio il 15 maggio e terminerà il 21 luglio.

Modalità di partecipazione
Il corso non richiede specifici requisiti di accesso, solo il desiderio di conoscere la realtà della ricerca clinica. La frequenza alle lezioni live non è obbligatoria ma altamente consigliata per poter interagire con i trainer e svolgere al meglio le attività pratiche. Anche chi non partecipa alle live può in ogni caso seguire il corso tramite le registrazioni e ottenere il certificato superando l’esame finale.

Contatti
email: info@missionecra.com
cell/whatsapp: +39 3791292555
sito: www.missionecra.com

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Randstad InHouse Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for an Administrative Assistant.

Location: Latina

We offer: a 12 month fixed term contract with the possibility of both personal and professional growth. Level and salary will be adjusted according to the candidate's experience.

Responsabilities:

• customer reception;
• event organization;
• event management.

Requirements:

• high school diploma or degree;
• good level of English is important as we work in an international environment;
• a person with a good interaction.

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be responsible for developing our Sourcing of Plastic suppliers to new heights? Do you want to make a difference for patients undergoing surgery by securing the compliance of the medical devices used by healthcare professionals? 

Here you have the opportunity to get an exciting and challenging job, as Principal Category Manager, in a international company. As Ferrosan Medical Devices is growing, you will be able to shape the job in our Strategic Sourcing Department to a large extent. The position refers to the Senior Manager of Strategic Sourcing.

The department Strategic Sourcing is part of Supply Chain Management, which is a central area in Ferrosan Medical Devices. Strategic Sourcing consists of 6 experienced Category Managers covering direct spend, CMOs and Indirect spend including equipment and machinery. The team is responsible for all aspects of supplier management including supplier selection, negotiation, and collaboration as well as risk mitigation, spend/savings program, and category strategies. 

Responsibilities
You get a central position, with responsibility for the collaboration and development of the company's Plastic Suppliers. There will be a great deal of contact with the suppliers, who are primarily in Europe, as well as a broad contact surface across Ferrosan Medical Devices.

Your main tasks will be:

• Establishment and maintenance of Category strategies.
• Daily handling and collaboration with our current Suppliers.
• Negotiations and conclusion of contracts.
• Development of the supplier base.
• Optimizing the processes and structure around the Suppliers.
• Participate in various product development and optimization projects

The overall purpose of the position is to ensure robust cooperation and management of our Plastic suppliers, this to reduce total costs through close cooperation, taking quality, reliability and risk management into account.

To be successful, you must internally work closely together with e.g. Finance, the Development department, the Quality organization and your colleagues in Supply Chain Management and Operations.

Your profile
The ideal candidate for the job holds experience from a similar role managing and leading Categories from a highly regulated industry such as medical devices, pharma, biotech, life science or similar. As a person you have a pragmatic approach, and you find solutions to identified problems.

• Minimum B.Sc. – ideally a degree at M.Sc. level as an Engineer, Economist or within Supply Chain.
• Minimum +5 years of experience within purchasing and/or Supply Chain.
• You have experience with Category Management and supplier handling.
• Demonstrated track record in finding pragmatic solutions to complex or challenging problems.
• Highly experienced in stakeholder management.
• Your work style is involving and impactful.
• You think in holistic terms and with a business-oriented approach to the solutions.
• You have created visible results in your current or previous roles.
• You have experience with GMP.
• Possess strong oral/written communication skills in English.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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Place of work: Pisa 

Type of contract: internship (onsite position)
Possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

• Supports development of P&MA assessments: overview of Italian landscape and competitors in the specific therapeutic area, identification of potential issues and hurdles.
• Supports the adaptation of economic models: Budget Impact Model (BIM) and cost-effectiveness model (CEM) and writing of the Economic Section of the AIFA P&R Dossier.
• Supports preparation of Pricing and Reimbursement (P&R) dossiers according to the Italian AIFA requirements (any kind of dossier, from medicinal specialties to generics, from new applications to renegotiation applications, etc.), and submission to the Italian Agency.
• Supports logistics of advisory boards with KOLs and/or payer experts (recruitment, contracting, reporting) and Face2Face/telephone interviews (recruitment, contracting, interview, reporting).

What are the requirements?

• Master's degree in Pharmaceutical Chemistry and Technology or Economics, with specialization in Health Economics.
• Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
• Ability to work in a team and aptitude for learning.

What we offer?

• Dynamic and challenging work environment with international projects.
• Ongoing training and opportunities for professional growth.

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With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock
exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe
who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around
150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for
common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.

Job purpose:

The resource, inserted in the Innovation&Omnichannel team of the Specialty and Primary Care Italy division, will be supported in a professional growth path aimed at understanding the activities and dynamics peculiar to a multinational company in the Pharmaceutical field. The goal training of the internship project will be the understanding of some key activities of the function, including the creation of effective and innovative omnichannel campaigns, as well as the scouting and implementation of innovation projects in Digital Health.

Key responsibilities:

1. Omnichannel:
• Omnichannel campaign creation: Supports the development of digital campaigns, bringing in creative ideas and optimizing touchpoints across various channels to ensure message consistency.
• Product and market analysis: Studies the market and competitors to provide strategic insights useful for improving product positioning and optimizing campaigns in Digital Health
• Supplier collaboration and management: Works with business stakeholders and coordinates activities with suppliers, ensuring timely collection of materials.
• Monitoring and Optimization: Monitors KPIs and collects data to improve campaign performance, suggesting corrective actions based on analytics.

2. Innovation:
• Innovation’s scouting: Researches new technologies and trends in digital health to improve business strategies. Proposes innovative solutions to maintain competitiveness.
• Identifying partnerships: Explores potential partnerships with technology companies and startups. Initiates early partnership moments to create shared value.
• Proof of Concept (PoC): Supports co-creation and monitoring of pilot projects to test new solutions. Monitors SAL and collects insights to evaluate the effectiveness of PoCs.
• Stakeholder Relations: Facilitates communication between internal teams and external partners to ensure project success. Maintains continuous and transparent information flow.

Required skills, qualifications, experience and behaviours:

• Good data analysis and interpretation of data skills
• Knowledge of marketing techniques and digital technologies
• Effectively communication skills with internal teams and vendors
• Willingness to innovate and research new technologies
• High level of proficiency with Office Suite (MS Word, MS Excel, MS PowerPoint).
• Excellent analytical skills
• Excellent communication skills
• Desire to work in cross-functional teams with a result driven approach
• Flexibility, proactiveness, goal-oriented approach, and a marketing-oriented mindset will be considered preferential attributes

Education (minimum/preferable): graduate in Management Engineering/Economics, with focus on innovation issues.
Knowledge of data analysis/data science methodologies and tools will be considered as a plus.

Languages skills: English B2

Previous working/experience: internship or abroad experiences will be considered as a plus.

 

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

 

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Employer: Novo Nordisk Engineering (NNE)

 Does the idea of developing business-critical data solutions excite you? Do you thrive on building cloud-based BI solutions and developing reports in Power BI and Excel? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Virum

The Role & Department
We are looking for a Data Analyst to join our team of in our department for Financial Systems. As a team, we are developing and maintaining applications within the Finance Domain. Furthermore, you will be a part of the cross organizational ERP project.
As our new Data Analyst, you will play a pivotal role in developing business critical data solutions for NNE, as you will participate in building our cloud-based data reporting solution while also ensuring a smooth transition from our current reporting environment.

Responsabilities
As Data Analyst, you’ll:

• Participate in project activities building a cloud-based Business Intelligence (BI) solution that integrates with Dynamics 365 ERP system.
• Develop new reports in the cloud, together with a dedicated and strong team of data analysts.
• In general build, change, and deploy reports in Power BI or Excel based on user Interpret and reconcile data from multiple sources.
• Handle ad hoc data requests from end users.
• Provide backend support for other applications within the Finance domain, e.g., Planning and Consolidation application as well as other systems.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• Excellent problem-solving and collaboration skills.
• A curious mindset and are a great team player.
• A strong understanding of business processes and the ability to translate user requirements into technical specifications
• Agility and the ability to prioritize urgent tasks.
• Excitement to build on the NNE culture of innovation.

We believe these qualifications are needed for you to do well in this role:

• Prior experience working as a Data Analyst with advanced skills in data analysis, pivot tables, and complex formulas.
• Strong knowledge of SQL, Power BI and ETL development with ability to write and optimize queries for data extraction and manipulation.
• Familiarity with Azure Synapse Analytics and knowledge of Microsoft Fabric are an advantage.
• Bachelor’s degree in business, Computer science, Engineering, or related fields.

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale.

Per rafforzamento del team di multinazionale operante nel settore della diagnostica molecolare, in particolare di soluzioni e test diagnostici molecolari per l'individuazione di agenti infettivi, ricerchiamo un/a:

FIELD APPLICATION & SERVICE SPECIALIST – CENTRO-SUD ITALIA

Zona di lavoro: Napoli/Roma con spostamenti e trasferte su tutto il Centro-Sud Italia

Contratto: a tempo indeterminato; CCNL Farmaceutico, Livello commisurato al livello di professionalità acquisito.
Si offre: Benefits correlati alla posizione quali, pc, cellulare, auto aziendale ad uso promiscuo.

Responsabilità:

• Organizza ed effettua training tecnico-applicativi presso le sedi degli utilizzatori;
• E’ referente diretto per domande tecniche ed applicative;
• Svolge presentazioni tecnico scientifiche sulle soluzioni offerte;
• Supervisiona, educa ed aiuta i clienti acquisiti nell’utilizzo ed applicazione dei prodotti diagnostici (strumentazione e reagenti);
• Prende parte a congressi e convegni scientifici del settore; collabora e supporta la rete vendita di zona;
• Gestisce delle fasi di prevendita e postvendita;
• Pianifica ed esegue in autonomia attività di installazione, assistenza e validazione delle apparecchiature con la garanzia del necessario approvvigionamento dei pezzi di ricambio;
• Risolve problemi, diagnosi e correzione in caso di malfunzionamenti del sistema;
• Analizza i dati strumentali e di laboratorio per attività di troubleshooting, per proposizione e valutazione della soluzione offerta rispetto alla routine attuale e per l'ulteriore sviluppo dei processi di supporto interno.

Requisiti:

• Laurea in discipline scientifiche o ingegneria (Biologia, Biotecnologia, Ingegneria Biomedica);
• Pregressa esperienza di almeno 1 anno con macchine da laboratorio di diagnostica anche complesse (la conoscenza del sistema di preparazione dei campioni automatico da laboratorio è considerata un forte plus);
• Ideale la pregressa esperienza di laboratorio su tecniche di Biologia Molecolare;
• Esperienza professionale nel trattare con i clienti;
• Gradita una buona conoscenza della lingua inglese;
• Buona conoscenza del pacchetto office e dei principali software informatici
• Elevata determinazione nel raggiungimento dei risultati;
• Ottime capacità relazionali e di comunicazione orale e scritta;
• Capacità di lavorare in modo autonomo, attento e strutturato;
• Buona metodologia di troubleshooting anche durante situazioni pressanti ed in emergenza;
• Flessibilità e dinamicità
• Disponibilità a viaggiare frequentemente sul territorio (anche 3-4 giorni alla settimana);
• Patente B.

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be part of the Clinical Insights Department at a company that has a unique impact on global healthcare? Are you ready to influence the future of hemostatic products and accessories? Can you help identify unmet user needs and integrate user experiences into product development? Then join Ferrosan Medical Devices as our User Insights Specialist. Every other second, Ferrosan Medical Devices’ products help surgeons and nurses control bleeding and avoid complications during surgical procedures. We make every second count in surgical care, and we need you on our team! 

Become part of our Clinical Insights team 
At Ferrosan Medical Devices, we develop hemostatic products that surgeons in over 100 countries use to manage bleeding during surgeries. We focus on creating user-friendly solutions that enhance the workflow for operating room nurses. We’ve been developing hemostatic products since 1947, and we take pride in contributing to improved patient outcomes in surgery.
 
Your new team, Clinical Insights, ensures user feedback is integrated throughout the development process—from idea conception to market release. Our deep understanding of user needs and environments guides our development process. We explore unmet user needs and transform them into product features that make a real difference for our users. We leverage usability expertise to bring the best possible products to market—ones that are effective, safe, and easy to use.

Responsibilities
You'll be warmly welcomed into our team of two, where helpfulness and a strong team spirit are key to achieving the best results. Clinical Insights is part of the New Business Development Department, working closely with Device R&D, Product Innovation, Product Development, and Commercial Development.

As part of the early-stage product innovation team, you'll help set the direction for product development based on user needs and market trends.

In this role, you will:

• Identify and explore unmet user needs within surgery
• Interpret user and market insights and present recommendations to the innovation team
• Generate usability engineering documentation and support risk management. 

Your profile

• You have an educational background in healthcare, life sciences, medical health sciences, or a related field—at least at the Bachelor's level
  
• You have a few years of experience in user needs identification and usability/human factors engineering, preferably in the Medtech Industry
• You know how to gather valuable insights from users using voice of customer and usability engineering methods, and you can translate these insights into product features and design requirements in collaboration with an innovation team
• You work diligently, in depth, and in a structured manner with multiple usability documents
• You have knowledge of the IEC 62366 usability engineering standard and FDA guidance for applying human factors and usability engineering to medical devices
• You have strong collaboration skills
• You are fluent in English, both written and spoken  

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

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Main Activities
- Svolgere attività analitiche specialistiche nel campo analitico-strumentale.
- Operare con autonomia all'interno dei lavori che gli vengono affidati dal Supervisore che lo coordina, nell'ambito di obiettivi prefissati o discussi.
- Eseguire tutte le operatività del laboratorio. Interagire autonomamente con altri laboratori / unità, nello svolgimento del lavoro affidatogli. Riportare autonomamente per iscritto i risultati di lavoro.

Fornire supporto per:
- Mantenimento dello stato di qualità dei laboratori, mediante il monitoraggio dello stato di pulizia, ordine e stato fisico (pareti, pavimenti ed arredi);
- Verifica della presenza di DPI, etichette per tossici e nocivi e corretto stoccaggio dei rifiuti;
- Verifica dello stato di calibrazione e manutenzione delle attrezzature (mediante controllo etichetta e del logbook);
- Controllo della strumentazione di stoccaggio (armadi aspirati) presente nei locali di competenza;
- Controllo dei materiali e i reagenti mediante verifica delle scadenze, stoccaggio idoneo e presenza dei MSDS.

Release Analitici:
- Eseguire le analisi e prove (Controlli chimico-fisici e biochimici) al fine di permettere il controllo efficiente ed affidabile delle materie prime, dei processi, degli API, intermedi e delle utilities (acqua
di processo e condensa del vapore puro) nel rispetto delle procedure e dei programmi stabiliti
- Eseguire le attivita analitiche del laboratorio chimico-fisici e biochimici degli studi di stabilità;
- Eseguire il campionamento delle materie prime;
- Eseguire il campionamento delle utilities (Acque di Processo e Condensa del Vapore pulito);
- Eseguire il controllo della cleaning degli impianti (Swab tests ed analisi delle Rinse water).

Laboratory Documentation Management and Training:
- Redigere le procedure del Laboratorio Chimico di sua competenza prima del loro utilizzo;
- Redigere Memo e Report analitici;
- Notificare tempestivamente i risultati non conformi ed eseguire le Investigazioni di Laboratorio, nella gestione degli OOS;
- Redigere documentazione su richiesta del responsabile.

Indagini /Deviazioni /Reclami /Change request:
- Comunicare ed assicurare che le deviazioni relative ad attività legate alle analisi di sua competenza siano opportunamente indagate e risolte;
- Assicurare che le CAPA relative assegnatele siano eseguite nei tempi prescritti,
- Comunicare ed assicurare che le Change requests relative ad attività di competenza siano opportunamente gestite e completate.

Collaborations:
- Fornire supporto tecnico per audit interni;
- Partecipare attivamente alla preparazione delle ispezioni.
- Fornire supporto tecnico per le qualifiche delle utilities/equipment.

Technical skills
• Elettroforesi (gel and capillary)
• Spettrofotometria
• FTNIR
• ELISA Test
• Test Enzimatici
• Test Cromatografici
• Esperienza nei software cromatografici come EmpowerTM.

 

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Aenova propone un ambiente di lavoro dinamico e sfidante, il cui obiettivo è garantire ai clienti prodotti di qualità per il benessere e la salute dei pazienti.

Qualità, miglioramento continuo e affidabilità sono valori profondamenti radicati nei nostri processi: Aenova offers excellent prospects for your career!

! Questa posizione funziona come candidatura spontanea aperta per i seguenti ruoli:

1. Technology Transfer Project Manager
2. Quality Control Chemical Analyst
3. Quality Control Microbiology Analyst
4. Quality Assurance Specialist

Specificare nella Motivation Letter per quale ruolo ci si sta candidando!

Sede: Latina
Ad oggi lo stabilimento di Latina è tra i più importanti al mondo per la produzione veterinaria conto terzi, avendo stabilito rapporti commerciali con quasi tutte le maggiori aziende di farmaci veterinari. Il sito offre una tecnologia all’avanguardia con un elevato livello di automazione e integrazione e garantisce servizi di produzione rispondenti ai più alti standard di qualità, con un eccellente track record di approvazioni da parte degli Enti Regolatori, tra cui EMA, FDA, ANVISA.

Profilo ideale:
Laurea sia triennale che magistrale in Chimica, CTF, Farmacia, Biologia, Biotecnologie, Ingegneria (tutte le branche).
Requisito fondamentale è la conoscenza della lingua inglese.

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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

2 Quality Technicians in process

I Quality technicians verranno inseriti/e nella linea “Modern Oral”, prodotti per uso orale, che contengono nicotina ad alta purezza, acqua e altri ingredienti alimentari di alta qualità.

Sede: Trieste (TS)

Contratto: a tempo determinato/indeterminato, CCNL Chimico Farmaceutico.
Orario di lavoro: full time, ciclo continuo | Disponibilità a lavorare su tre turni da lunedì a venerdì.

Responsabilità:

• Campionamento e rilevazione di eventuali non conformità durante la produzione.
• Controlli in process durante la produzione (es. relativi a peso, misura) prodotti per uso orale HACCP.
• Controlli in process durante la produzione (es. relativi a peso, misura, pH, dimensioni) e redazione di certificati analitici sulla base di specifiche predefinite per prodotti farmaceutici.

Requisiti:

• Laurea in materie scientifiche.
• Esperienza di almeno 6 mesi maturata nell'area Controllo Qualità in siti produttivi farmaceutici o alimentari, utilizzando GC e SPETTROSCOPIA.
• Conoscenza delle normative HACCP e/o GMP.
• Richiesta la conoscenza della lingua inglese.

Completano il profilo:

• Buone capacità di comunicazione.
• Sapere lavorare in autonomia nel rispetto delle normative Qualità HACCP/GMP.
• Capacità organizzative e di pianificazione. 
• Propensione al lavoro in team e flessibilità.
• Propensione alla collaborazione e alla condivisione del proprio know-how.
  
  

BAT TRIESTE è parte del Gruppo BAT, fondato nel 1902, con sede a Londra. Leader mondiale nei beni di largo consumo con un portafoglio prodotti multi-category nel settore del tabacco, BAT impiega oggi oltre 52.000 persone, opera in più di 175 mercati e ha 75 stabilimenti produttivi su scala globale.

A settembre 2021 BAT Italia ha annunciato la costruzione dell’ ”A Better Tomorrow™ Innovation Hub", nella città di Trieste: un centro di innovazione e sostenibilità di livello mondiale per un investimento totale fino a 500 milioni di euro in 5 anni. Uno spazio di oltre 20mila metri quadrati che oltre ad ospitare un nuovo centro di produzione per i prodotti a potenziale rischio ridotto di BAT (in cui saranno sviluppati anche dei prodotti per la terapia sostitutiva della nicotina), ospiterà anche una Digital Boutique, ossia un laboratorio di innovazione e centro di eccellenza per la trasformazione e l'accelerazione digitale di BAT.

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Per candidarti alla Job incontra dal vivo i selezionatori di BSP Pharmaceuticals a ROMA, il 29 ottobre.

We are currently looking for a Sterile Operator Stage - that will mainly ensure:

Main Activities:

• Perform dissolution and filtration of pharmaceuticals according to the directions on Batch Records;
• Complete Batch Record and departmental documentation related to duties performed;
• Perform the washing and sterilization of the tanks present within the Sterile Department following the indications described on the current SOPs;
• Provide preparation of disinfectants for periodic cleaning of the Sterile and Pre-sterile Area as described on current SOPs;
• Perform the periodic checks of proper functionality of the machines and equipment in the preparation room as described on the current SOPs;
• Take care of the machinery, materials and work environment, reporting any anomalies to the supervisor in a timely manner;
• Perform the cleaning of the Sterile area at the end of Production activities in accordance with current SOPs

Requirements:

• Master's Degree in Chemistry, Chemistry and Pharmaceutical Technology, Biology, Pharmacy…
• Professional knowledge of English
• Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP.

 

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Employer: Novo Nordisk - Denmark

Turn your master’s degree into a global career​ from September 2025!

‎Our global Graduate Programme is designed to bring together change makers with a diversity of perspectives and equip them with the tools needed to accelerate their personal and professional development. The two-year programme allows you to explore the world while developing your career. You will be taken on three to four rotations around the globe where you will work in a fast-paced environment with plenty of growth opportunities. You will be exposed to different parts of the Novo Nordisk value chain while being challenged to explore your boundaries and reach your full potential. 

After successfully completing the programme, you will be equipped with professional and personal skills to embark on your global career with the guarantee of a position at Novo Nordisk.

We open for applications 1 November 2024 for graduate careers starting 1 September 2025.

What is the Graduate Programme?
The Graduate Programme is a two-year, global career journey with a minimum of three rotations including at least one rotation outside your home country. The destination depends on the specific graduate programme track but it could for instance be in one of the Novo Nordisk sites in Denmark, our International Operations (IO) Strategic Head Office in Zurich, an IO Regional Office or one of our many affiliates globally.

Is the Graduate Programme paid?
Yes, the Graduate Programme is a full-time position, and we offer a competitive entry level salary. The compensation and benefits package includes components such as pension and health insurance, based on local terms and is applicable to the country you are hired in.

Application requirements
Applicants must have a recent and relevant master’s degree* and international experience; for example, working, volunteering or from studying a full semester abroad.

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Employer: Novo Nordisk Engineering (NNE)

As a company NNE value the knowledge that student workers, interns and thesis writers bring to their company. NNE offers specific opportunities for motivated and ambitious students who are eager to pursue careers in the pharmaceutical industry:

1. Student internships
2. Student jobs
3. Master’s thesis projects

1. STUDENT INTERNSHIPS
An internship will provide you with valuable work experience and inside knowledge of the various types of positions and responsibilities at NNE. An internship usually lasts three to six months and assignments vary. Positions are both paid and unpaid and become available throughout the year.

Who can apply?
NNE’s student internship program is designed for students who are enrolled in a degree program (BSc, MSc or MBA degree level) at an accredited college or university.

Engineers
The internships for engineering students are targeted at academic majors in:

• Automation
• Architecture and design
• Structural engineering
• Civil engineering
• Mechanical and electrical engineering
• Chemistry, food, biotechnology, dairy, food science or similar areas

Other areas
We also offer internships in the following areas:

• Finance/project economy
• Human resources
• IT 
• Purchasing
• Sales and marketing
  
  

2. STUDENT JOBS
Gaining work experience is the perfect way to get a better understanding of roles and assignments you wish to engage in once you finish university. You will obtain valuable industry insight and learn more about yourself, your strengths and your development potential.

We offer between 10-20 hours a week all depending on how you can combine the job with your studies, as we know you need the flexibility, also around holiday and exam periods. Few positions are full-time positions.

Responsibilities
The responsibilities of student staff range from providing customer service and technical support, preparing for and participating in events held by our offices to assisting with various projects as needed.

Who can apply?
Student jobs are designed for students who are enrolled as degree-seeking students at an accredited college or university. Student jobs are available at all our offices worldwide and are posted as needed.

Requirements
You are enrolled in a university or college program.

3. MASTER’S THESIS PROJECTS
A Master’s thesis project is a way for us to get to know you as a student and also to learn about the latest developments in the academic world. Working on a Master’s thesis is your first step into working life and, we hope, a new acquaintance with NNE.

Who can apply?
We invite Master’s degree students to use NNE as a case study in dissertations or major projects within:

• Automation
• Architecture and design
• Structural engineering
• Civil engineering
• Mechanical and electrical engineering
• Chemistry, food, biotechnology, dairy, food science or similar areas

Available case projects
When we have Master’s thesis projects available, we list them on our career site at www.nne.com. If no projects are announced, but you have your own idea that you think could be implemented together with us, you are welcome to contact us.

⚠️ To submit your application, please go to the following site: 
https://www.nne.com/careers/entry-level/

 -

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Randstad Italia spa, specialty pharma, ricerca per strutturate aziende multinazionali del territorio della provincia di Latina e della zona di Pomezia dei QC Analyst.

Sede di lavoro: Provincia di Latina

Mansioni:

• esecuzione dei test analitici su prodotti chimici e materie prime attraverso attività quali cromatografia liquida (HPLC), gascromatografia. titolazione potenziometrica, spettrografia, cromatografia su strato sottile (TLC).
• assicurazione della calibrazione giornaliera e periodica delle apparecchiature, approvvigionamenti e smaltimenti.
• documentazione del processo di lavoro e dei risultati dei test in conformità alle normative GMP

Requisiti necessari:

• laurea in discipline scientifiche quali chimica e tecnologie farmaceutiche, farmacia, chimica od affini.
• esperienza di almeno 6 mesi in ruolo analogo
• Caratteristiche personali di serietà, attenzione e capacità di operare nel rispetto dei ruoli completano il profilo.

Modalità di lavoro: on site, con disponibilità al lavoro su 3 turni (6/14, 14/22, 14/22) dal Lunedì alla Domenica con giorni di riposo compensativo.

Il livello di inquadramento, la retribuzione e la durata contrattuale saranno stabilite sulla base della reale esperienza del candidato, si offrono reali ed interessanti opportunità di crescita personale e professionale.

 

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Randstad Inhouse Specialty Pharma, ricerca per strutturata azienda multinazionale neolaureati in materie ingegneristiche (ingegneria informatica, elettronica, meccanica, dell’automazione, medicale o bioingegneria) per formarsi come CSV, Computer System Validation.

Sede di lavoro: Catania

Si offre: contratto di somministrazione in ambiente dinamico e stimolante con prospettive personali e professionali. La durata del contratto e l’inquadramento saranno commisurati alla reale esperienza del candidato.

Mansioni:

• La risorsa supporterà gli aspetti inerenti l’intero ciclo di vita e di convalida dei sistemi di automazione e la compliance documentale degli stessi,
• L’ installazione, configurazione, commissioning e supporto alla convalida degli equipment.

Requisiti richiesti

• laurea in materie ingegneristiche;
• conoscenza, anche accademica, dei principi di Data Integrity;
• fluente conoscenza della lingua inglese.

La capacità di analisi e sintesi, la propensione ad interfacciarsi costantemente con colleghi e responsabili, unitamente a curiosità e motivazione al ruolo completano il profilo.

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Randstad InHouse Specialty Pharma ricerca per un'importante azienda multinazionale del settore chimico farmaceutico un addetto agli affari regolatori.

Sede di lavoro: Provincia di Frosinone

Si offre: contratto in somministrazione di 6 mesi con possibilità di proroghe ed opportunità future di crescita personale e professionale.
Il livello di inquadramento e la retribuzione saranno stabilite sulla base della reale esperienza del candidato.

Mansioni:

• scrittura ed esame dei dossier normativi per garantire gli standard correnti;
• verifica della compliance del sito produttivo, secondo norme locali ed internazionali;
• supporto nel confronto con gli enti normativi;
• esame dei file normativi per i prodotti commerciali (MAA, NDA, BLA, ANDA) e prodotti clinici (IMPD, IND).

Requisiti richiesti:

• laurea in discipline scientifiche e gradito master in affari regolatori
• esperienza pregressa nel ruolo di almeno un anno;
• ottima padronanza della lingua inglese;
• ottima conoscenza delle linee guida Emea, USA, Giappone e Cina.

Senso di responsabilità, capacità di lavorare sotto stress ed orientamento al risultato completano il profilo.

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be part of an innovative IT-team within a company making a global impact on healthcare? Join us at Ferrosan Medical Devices, where you can shape the future of surgical care while developing your skills in a fast-paced environment. Every other second our products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!

We expand our team with a Data Partner role that will serve as a strategic link between our data science team and our business units. This role is crucial in driving the integration of data insights into business decisions, enhancing data literacy, and fostering a data-centric culture. Your role will be to ensure that our data-driven initiatives support our overall business objectives and generate measurable value.

Responsibilities
Your role will amongst other be to:

• Collaborate with our business units to identify data needs, drive data initiatives, and deliver actionable insights for strategic decisions.
• Translate complex data analytics into clear, actionable business recommendations.
• Lead the implementation of data governance standards to ensure data quality and integrity across the organization.
• Manage data-related projects, including coordinating with stakeholders to ensure successful execution and alignment with business goals.
• Drive the development of data literacy within the organization, empowering business units to make data-informed decisions.
• Communicate findings and strategies effectively to diverse stakeholders through reports, dashboards, and presentations.

Your profile
A passion for data is an absolute must and an insight into how to use the data for management insights, too, and other than that you can probably tick off all or some of the below requirements:

• A bachelor’s or master’s degree in data science, business analytics, information technology, or a related field.
• Proven experience in a data-focused role, ideally within a business environment delivering strategic insights.
• Proficiency in data analysis and visualization tools (e.g., SQL, Python, R) and experience with business intelligence platforms (e.g., Power BI).
• Strong project management skills, with the ability to drive data initiatives from concept through execution.
• Excellent communication and stakeholder management skills, with the ability to translate data concepts into business terms.
• A proactive, analytical mindset with a passion for using data to drive business success.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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Randstad Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for an In-Market Supply Chain JR. Planner.

Location: Milan

We offer: a 12 month fixed term contract with the possibility of both personal and professional growth.
Level and salary will be adjusted according to the candidate's experience.

Responsabilities:

• manages forecast and replenishment (using the planning tool OMP) to local warehouse.
• weekly check and update the PCT05 to ensure healthy level of inventory.
• manages, plans and initiates import and export licenses for the full narcotic portfolio. Monitor expiry dates of licenses.
• develops weekly shipping schedules and creates delivery notes for Italy.
• manages New Artwork Implementation Planning and Shelf-Life Planning.
• communicates with manufacturing sites to ensure uninterrupted supply to the markets.
• maintains Master Data Planning Parameters for ERP (SAP) and Planning System (OMP).

Requirements:

• has a degree from university, minimum a B.Sc. or three years equivalent upper education;
• acts with integrity and assumes full responsibility, accountability for assigned tasks;
• office, and solid excel expertise;
• good level of English is important as we work in an international environment;
• attention to details for recurrent work related to supply chain activities, familiarity with planning and good level of organization;
• has an open and curious mindset and happily shares and discusses ideas.

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Ruolo: CSV Intern

Sede: Latina e/o da remoto con disponibilità a viaggiare su tutto il Territorio Nazionale secondo le necessità di progetto per il raggiungimento degli stabilimenti dei clienti.
Contratto: iniziale stage extracurriculare, finalizzato ad assunzione in apprendistato.
Orario di lavoro: full time

Disponibilità: Immediata

S4BT è un’Azienda di oltre 80 specialisti e specialiste, che da quasi 30 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo, in diversi ambiti come qualità, ingegneria, Project
Management, Validazioni, Tech Transfer, Computer System Validation e altro.
Proprio per l’area Computer System Validation, ricerchiamo un profilo neolaureato che, grazie al supporto di un tutor, intraprenderà un percorso formativo tale da ricoprire il ruolo di CSV Intern.

Come CSV Intern, di cosa ti occuperai?

♦︎ Avrai l’opportunità di intraprendere un percorso formativo che ti permetterà di eseguire attività di progetto in ambito Computer System Validation (redazione di documenti ed esecuzione in campo di protocolli di test, per la convalida dei sistemi computerizzati utilizzati in ambito GxP) in termini di:

• Partecipazione a corsi di formazioni erogati all’interno dell’azienda.
• Affiancamento nei progetti assegnati.

♦︎ Parteciperai a meeting di condivisione di progetto e di area con tutto il team CSV.

Cosa ci piace in un/a candidato/a?

• Un/a vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro.
• L’attitudine a far proprie le linee guida aziendali.
• La curiosità, l’entusiasmo e l’energia.
• La partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Cosa richiediamo?

• Laurea triennale o magistrale in discipline tecnico-ingegneristiche e chimico-farmaceutiche.
• Interesse e curiosità nella convalida di sistemi computerizzati ed infrastrutture di rete.
• Interesse e curiosità in ambito Quality Assurance and Compliance.
• Buona conoscenza della lingua Inglese sia scritta che parlata (livello minimo B1).
• Buona conoscenza del pacchetto Office.

Se ti interessa la posizione vieni a conoscerci a Roma, il 29 ottobre 2024!

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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

Proponiamo un’interessante opportunità come:

Quality Assurance Specialist – Master Batch Record 

L’azienda nostra cliente è un’azienda globale leader nella produzione di farmaci sterili.

Sede: Monza, sede raggiungibile facilmente da Milano anche con servizio di navetta gratuita dalla Stazione di Monza.

Contratto: di 12 mesi, scopo assunzione, CCNL Chimico Farmaceutico, livello C2. Mensa, smart working 3 giorni su 5 una volta raggiunto un buon livello di autonomia.

Responsabilità:

• I candidati scelti verranno inseriti all’interno del Master Batch Record Team che fa parte del dipartimento MS&T (Manufacturing, Science and Technology), dipartimento multifunzionale e multidisciplinare che lavora al trasferimento di commesse - da R&D o da altri stabilimenti – sulle proprie linee produttive.
• I candidati scelti verranno formati e affiancati fino a raggiungere autonomia professionale nella scrittura e gestione documentale del documento Master Batch Record alla base di ogni processo produttivo farmaceutico GMP.
• Lavoreranno a stretto contatto con le altre funzioni del MS&T (Regolatorio, al Tech Transfer, tecnologia di processo, project manager, etc) e con i clienti stessi a livello Global, acquisendo una overview privilegiata dei processi e degli impatti regolatori, di processo e tecnologici sottostanti all’avviamento o alla modifica di ogni processo produttivo farmaceutico.

Requisiti:
Il profilo ricercato possiede:

• Una laurea di II livello in ambito scientifico (preferibilmente in CTF).
• Ha maturato un'esperienza di 6 mesi/1 anno, in ambito Quality di un’azienda produttiva farmaceutica.
• Ha un’ottima conoscenza della lingua inglese.
• L’aver visto o gestito il Master Batch record o l’aver effettuato Batch Record Review in formato elettronico costituisce titolo preferenziale. 

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Employer: AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.  

The Role & Department
The QA Manufacturing Support Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

Location: Copenhagen, Denmark

Responsibilities

• Provide an “on-line” Quality presence in the production area during manufacture regarding on the line documents and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
• Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
• Conduct batch record “Stage Approval” as part of batch release process.
• Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
• Shipping/ prepacking approval.
• Manufacturing label management. 
• Archiving.
• Review and approval of validation/ qualification documentation.
• Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
• Work with manufacturing to drive improvements in GMP compliance across all shifts.
• Support manufacturing during batch review with Good Documentation Practice related queries.
• Perform Quality review and approval of deviations (DEVs), change controls (CRs) and CAPAs.
• Buffer and media MPR review and approval

Requirements  

• Bachelor's and/or Master’s degree in Natural Sciences.
• Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, medical laboratory technology including 3-5 years experience within a GMP environment in the Pharma Industry.
• Experience with BPR/MPR review will be a plus.
• Previous biopharma experience is preferred but not a requirement.
• Strong working knowledge of the principles and guidelines for GMP is a plus.
• Strong decision maker and ‘can do’ attitude. 
• Excellent written and verbal communication skills to internal and external stakeholders.
• Ability to work in a fast paced, matrix environment is essential.
• Capable of working to deadlines and prioritizing multiple tasks.
• Flexibility to meet changing needs and priorities of the business.
• Experience working in a GMP aseptic manufacturing environment will be a plus.  

 

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Per candidarti alla Job incontra dal vivo i selezionatori di BSP Pharmaceuticals a ROMA, il 29 ottobre.

Posizione
We are currently looking for a QA Stage - that will mainly ensure:

Main Activities:

• Batch record review
  Ensure compliance and completeness of the Batch record, through collection and analysis of all necessary documentation, documentary verification of material approval status, check list and current SOPs, in compliance with applicable regulations (laws, GMP regulations, FDA, etc.) and company quality standards.
• Investigation Management
  Support the supervisor in managing investigation of deviations and complaints, preparation of appropriate reporting, complete with corrective and preventive actions in compliance with company procedures.
• Planning GMP Training
  Ensure, through the coordination and control of the employee structure, efficient planning of training required by GMP standards towards all personnel, through analysis of training needs and coordination of the organizational needs of different functions, in compliance with GMP standards.
• Quality
  Ensure compliance with company quality standards, through the implementation of procedures related to areas of responsibility, in accordance with company quality policies and procedures.

Requirements:

• MA degree (CTF/Chemistry, Pharmacy, Biology…)
• Knowledge of GMP
• English working knowledge
• Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP

 

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Randstad Inhouse Specialty Pharma, ricerca per strutturata azienda multinazionale un QA che si occuperà di supervisionare il processo di quality risk management per il sito e della valutazione dei rischi sia per il prodotto che per il processo.

Sede di lavoro: Catania

Si offre: contratto di somministrazione iniziale a tempo determinato con possibilità di crescita personale e professionale, e livello da definire sulla base della reale esperienza del candidato.

Mansioni:

• preparazione, revisione ed approvazione della documentazione, al fine di assicurare che sia in linea con le normative e con le procedure del sito.
• implementazione e completamento delle azioni correttive o preventive (CAPA) e assicurazione dell'applicazione dei principi ALCOA alla propria area, comunicando le deviazioni dal processo standard.
• supporto del QA Compliance Sr Supervisor per tutte le questioni di qualità inerenti il prodotto.
• attuazione all'interno dello stabilimento le politiche e linee guida “Environmental, Health and Safety” internazionali per la sua parte di competenza.

Requisiti richiesti:

• laurea in farmacia, CTF, chimica o discipline scientifiche;
• esperienza almeno biennale in ruolo e contesto analogo;
• conoscenza delle attività e dei processi di produzione e gestione aziendale della qualità, delle GMP e del risk management;
• buona conoscenza della lingua inglese sia scritta che parlata;
• ottima padronanza degli strumenti informatici e conoscenza dei software operativi e dei principali strumenti di calcolo statistico;
• il possesso di certificazione green belt o superiore sarà considerato requisito preferenziale.

L’orientamento al team working, la capacità di mediazione e la predisposizione al raggiungimento degli obiettivi completano il profilo.

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Per candidarti alla Job incontra dal vivo i selezionatori di BSP Pharmaceuticals a ROMA, il 29 ottobre.

Posizione
We are currently looking for a QC Analyst Stage- that will mainly ensure:

Main Activities - QC Microbiology Analyst:
· Daily use and control of the main laboratory equipment (chromogenic kinetic, isolator, biolog);
· Microbiological analysis of raw materials, semi-finished and finished products according to current analytical methods;
· Sterility testing within the isolator system;
· Microbiological validation activities;
· Issuance and review of laboratory documentation;
· Preparation and sterilization of culture medium;

Main Activities - QC Chemical Analyst:
· Chemical analysis of raw materials, semi-finished and finished products according to current analytical methods or Pharmacopoeias;
· Daily use and control of the main laboratory equipment (HPLC, UPLC, UV, SoloVPE, KF, IR);
· Evaluation of analytical results obtained;
· Drafting of GMP documentation;
· Proper handling and use of reagents and laboratory standards;
· Use of major data processing and management software (Empower, Totalchrom, UV WinLab ES, Excel, LIMS).

Main Requirements:
· MA degree (CTF/Chemistry/Biology/Biotechnology)
· Available on working on shifts
· English working knowledge
· Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP.

 

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be a part of an engineering project team in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.   

Every 2nd second, Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team! 

You will become responsible for specifying and implementing next generation manufacturing equipment for internal paste filling processes
We are expanding our production capability in site Søborg as we are approaching new markets with our products. To succeed with this, we are looking for a new colleague to join our department of Technology Innovation, Internal Engineering.

Responsibilities
As our new Senior Project Engineer, you will be responsible for developing and specifying new filling production equipment – both for development purposes and capacity expansion of SURGIFLO®. Here you will be responsible for developing equipment specifications and production equipment to produce within these specifications. You will join a team of project engineers responsible for development of all internal processes and equipment in site Søborg, for the manufacturing of SURGIFLO® and other products.

In collaboration with stakeholders such as team members from Product Innovation and Process Support, you will prepare user requirement specifications, development studies, validation plans, and other documentation needed to ensure that we have effective processes, equipment, and high-quality products. Success in this role will require a structured and data-based approach, where you ensure and verify the correct documentation, and process impact. 

A lot of your work will include close cooperation with both our external machine builders, manufacturing partners and internal stakeholders like Product Innovation, Quality Assurance and Manufacturing. 

Your profile
As a person, you are a team player, and you are skilled in keeping an overview of your tasks. You are quality minded, and you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments. You thrive in a high pace environment.

You have a solid data-based approach to your work, and you understand the importance of documentation and processes. At the same time, you thrive when interacting with a range of different people. You have the skills to communicate and convey technical matters into more tangible formulations. Your language proficiency in both written and spoken English is at a professional level as many of your tasks will be executed in collaboration with English speaking colleagues.

Qualifications
Ideally, you hold an Engineering degree or similar and experience with specifying automated manufacturing equipment for manufacturing of medical devices (not a requirement).

Other relevant qualifications are:

• Experience with filling, assembly, or packaging of pharmaceutical products.
• Experience with specifying manufacturing equipment for other industries; food, automotive/other.
• Experience with and understanding of GMP, process risk management, validation, and qualification of production processes.
• Experience with the design control disciplines.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

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Employer: Vestas

The Vestas Global Graduate Programme is an important part of our talent strategy. Through the programme, we aim to seek out the future people- and business leaders, specialists, and project managers that can help us reach our ambitious objectives – and make the world a better place while doing so.

The programme is the ideal opportunity for you to embark on an exciting global career while contributing to the solution of one of the most urgent challenges of our time: the climate crisis.

Do you want to play a pivotal part in the green energy transition?

The four areas of interest:

1. Business, Commercial & Strategy
2. Digital, IT & Projects
3. Supply Chain, Service & Logistics
4. Engineering, R&D & Innovation

How it works?
As a global programme, the Vestas Global Graduate Programme provides you with the opportunity to work in two different areas and locations of our organisation, allowing you to gain a thorough understanding of our purpose, values, and culture. Throughout the two years, you will get two rotations of 12 months each, starting in September. You will be exposed to five modules, each with a different leadership focus. As a Graduate, you will hold a full-time position where you will be equipped with the tools, support, and knowledge you need to succeed. The salary offered is comparable to an entry level position depending on the country in which you are hired.

When does the Graduate Program start?
The recruitment window for the 2025 Vestas Global Graduate Programme will open 1st of December 2024 and close on the 15th of January 2025 at 23.59 CET.

For foreign students:
In order to qualify for the Vestas Global Graduate Programme, you must already have completed either your Bachelor’s or Master’s degree and possess a valid work permit in the country that you are applying for. 

Further information: 
https://www.vestas.com/en/careers/early-careers/graduate-programme

⚠️ To submit your application, please go to the following site:
https://www.vestas.com/en/careers/early-careers/graduate-programme

-

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Employer: Novo Nordisk Engineering (NNE)

Does the idea of being a part of NNE’s all-time largest Process Automation team excite you? And do you thrive on solving complex challenges and driving innovation? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg

The Role & Department
We are looking for curious and experienced colleagues seeking the opportunity to join a fantastic company, where we together have the aspiration of becoming best in class within Automation Solutions for Pharmaceutical Engineering.

The Process Automation teamwork with consultancy, design & development, implementation, and validation of Automation solutions for the Pharma and Biotech industries. We work in projects and base our solutions on a deep understanding of our customers’ production processes – and if standard components can’t do the job, we develop our own. We are skilled in a broad range of process areas within API production, e.g. fermentation, recovery and purification, utility, and cleaning systems. We are right now looking into a long, exciting pipeline of large data driven, greenfield plants with modular/scalable designs.

You will be working in an enthusiastic and exciting team with more than 60 colleagues. Furthermore, you will become part of a global Process Automation team with more than 125 motivated employees. You will discover that your future colleagues are highly professional and forthcoming in welcoming you to the team.

Responsabilities

• Advising customers on their selection of automation solutions
• Designing, developing, implementing, qualifying and supporting Process Control Systems (PCS/DCS)
• Interacting with process experts and colleagues with expertise in surrounding systems and equipment like MES, Historian systems, instruments, production equipment etc.
• Developing and optimizing automation methods and strategies to meet our customers’ needs and sharing working knowledge with colleagues and partners
• Forming the basis of automation strategies and architectures to support our sister departments internationally and expand NNE’s Process Automation engagement
  

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• Understand your colleagues’ individual and cultural differences.
• A good listener who always comes with solutions.
• Able to prioritize urgent tasks, flag concerns, and collaborate effectively.
• Eager to learn and are excited to build on the NNE culture of innovation.
• Reliable and committed to contributing positively to the team.
• Appreciative of feedback because it contributes to your growth.

In all positions there are some things that are needed, and others a bonus.
We believe these qualifications are needed for you to do well in this role:

• You have 3 years or more of working experience and hold a degree as an engineer, ideally within electrical, automation, process or marine engineering.
• You have 2 years or more of working experience with PCS/DCS Application development (for example 800xA or SattLine), working in GMP/GAMP environment or with execution of Automation projects
  Knowledge of batch production is valued.
• You have an interest of working with PCS/DCS Application development (800xA or SattLine).
• You find the GMP/GAMP environment exciting.
• If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Employer: Ferrosan Medical Devices

Introduction
Do you want to be a part of the IT department in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, where we are ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop your skills further.

Every 2nd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!

About Ferrosan Medical Devices A/S
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global MedTech partners. Innovative ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.

Role summary
As our IT/OT Engineer, you will be responsible for managing and optimizing our hybrid IT/OT-environment. This role involves maintaining the stability, security, and performance of IT/OT-systems, ensuring seamless integration and operational efficiency.

Responsibilities

• Ensure continued compliance with GxP-regulations, guidelines and internal procedures
• Manage and maintain IT/OT-infrastructure, including servers, networks, and storage systems across multiple sites
• Implement measures to protect IT/OT-systems
• Troubleshoot and resolve system issues in a timely manner
• Collaborate with cross-functional teams to ensure IT/OT alignment and integration
• Develop and maintain system documentation and standard operating procedures
• Conduct system performance tuning and capacity planning
• Participate in IT/OT projects e.g. implementation of SCADA-solutions
• Participate in disaster recovery planning and execution

Your profile

• Preferably a Bachelor’s degree in Computer Science, Information Technology, or related field
• A minimum of 5 years of experience in IT/OT system administration in a regulated industry
• Proficiency in managing Windows and Linux servers
• Strong understanding of network protocols, firewalls, and security measures
• Experience with virtualization technologies such as VMware or Hyper-V
• Knowledge of industrial control systems (ICS) and supervisory control and data acquisition (SCADA) systems
• Excellent problem-solving skills and attention to detail
• Strong communication and interpersonal skills

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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CONTEXT, MAIN ACTIVITIES AND RESPONSIBILITIES
● Works closely with the Medical department to establish a medical foot-print for Laboratori Guidotti.
● Establishes, develops and manages collaborative relationships with key medical experts and opinion leaders of Italy related to any current and future disease areas relevant for Laboratory Guidotti (diabetes area in particular).
● Drives disease awareness in providing external medical disease education and – when appropriate- setting up local scientific programs, such as symposia, regional advisory boards, or scientific meetings in accordance with the respective Laboratori Guidotti disease plans.
● Coordinates and pro-actively contributes to all pre-launch and life cycle activities any pipeline products.
● Provides medical support and medical information on unsolicited HCP requests related to any Laboratori Guidotti in-line and pipe-line products in accordance with the relevant Menarini processes and the Italian regulations.
● Is an active member of scientific and educational interactions with therapeutic specialists on diagnostic and clinically relevant aspects of any therapeutic areas in which Laboratori Guidotti is active.
● Locally facilitates any patient access programs (EAP) to address high unmet medical needs.
● Collects competitive intelligence and market insights within the region on diagnostic methods and treatment paradigms of any therapeutic areas relevant for Laboratori Guidotti.
● Pro-actively supports internal medical knowledge (reps) on any relevant disease and product related aspects.
● Manages/supports local aspects of investigator-initiated trials or other research projects; on request through Global Clinical Operations, supports delivery of patient enrolment in Laboratori Guidotti clinical trials.
● Ensures legal excellence and compliance in all medical activities as per Laboratori Guidotti SOPs and local regulations List the core areas of responsibility.

JOB REQUIREMENTS
● A strong bio-science education background.
● Doctorate degree (MD, PhD, PharmD) is preferred.
● Ability to understand and effectively communicate scientific and medical information to both internal and a variety of external customers.
● Mobile, willing to travel extensively in the region.
● Strong communication skills, open style & pro-active.
● Fluent English and Italian is essential.

BASED: Pisa

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Il nostro cliente è un’azienda italiana leader nel settore degli integratori alimentari, dei dispositivi medici e dei farmaci, impegnata nel migliorare la salute e il benessere delle persone attraverso prodotti di alta qualità.

Ricerchiamo un/a INFORMATORE/TRICE SCIENTIFICO DEL FARMACO

Inizio previsto: gennaio 2025
Contratto: Assunzione diretta da dipendente secondo il CCNL Commercio, inquadramento e durata contrattuale variano sulla base dell’esperienza del candidato.
Completano l’offerta economica: Bonus variabile al raggiungimento dei KPI concordati, benefits (auto aziendale ad uso promiscuo).

La posizione offre l'opportunità di rappresentare e promuovere i prodotti dell’azienda presso medici di medicina generale, farmacisti e medici specialisti in area: ginecologia, gastroenterologia, oncologia e nutrizione.

Responsabilità:

• Presentare in modo efficace i prodotti ai professionisti sanitari.
• Fornire informazioni scientifiche accurate e aggiornate sui nostri prodotti.
• Collaborare al raggiungimento degli obiettivi di vendita.
• Partecipare a conferenze ed eventi per promuovere la conoscenza dei prodotti.
• Monitorare e riportare le tendenze di mercato e le attività della concorrenza.

Requisiti:

• Laurea scientifica in base al DL 219/2006 e successivi.
• Esperienza precedente come Informatore Scientifico del Farmaco.
• Eccellenti capacità di comunicazione e presentazione.
• Conoscenza approfondita del settore farmaceutico, dei dispositivi medici e degli integratori alimentari.
• Orientamento ai risultati e capacità di lavorare in team.

Zone lavoro:

• Monza Brianza
• Piacenza
• Parma
• Reggio Calabria
• Messina
• Sassari

Nella cover letter specificare l'area geografica di interesse.

 

 

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Employer: Novo Nordisk - Denmark

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Locations: We are looking for candidates to all our locations. This specific pipeline covers on-site positions in Greater Copenhagen area e.g.: Bagsværd, Gentofte, Søborg, Lyngby, Måløv, Kirke Værløse.

The Role & Department
Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Are you driven by automation and digitalization of the Novo Nordisk manufacturing value chain? Look no further!

Joining the Automation Engineers Pipeline

By applying for the pipeline, you will be considered as a potential match for on-site automation related positions, which align with your background, skills, and interests across various areas in Denmark.

Due to the expansion of our activities in all business areas and sites, we are currently seeking talents for many different teams across Novo Nordisk, such as Advanced automation, Manufacturing Execution Systems (MES), and Collaborative- and industrial robotics. We encourage you to read more detailed information about the different roles and areas through this link: https://www.novonordisk.com/careers/campaigns/automation-engineer-process-digitalization.html

Requirements
We are looking for someone with an innovative and solution-oriented mindset. As you will be working and collaborating with people from various departments in the organization, it would be preferable that you are ready to take the lead on deploying solutions that bring value.

To apply to our pipeline, we expect that you:

• Are newly graduated with a bachelor’s or master’s degree within e.g., IT, Automation, or Robotics
• Would like to build on your skills and experience together with highly dedicated colleagues.
• Are proactive, solution-oriented, like to share your knowledge and collaborate effectively.
• Work systematically and with the ability to develop and implement practical actions to deal with issues.
• Have proficient oral and written communications skills in English. Danish language skills are great advantage.
• As documentation according to Good Manufacturing Practice (GMP), rules are part of our daily work, it is important that you thrive in ensuring that all your work is well documented.

 

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Randstad InHouse Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for a Employee & Labor Specialist.

The Role:

• The Employee & Labor Relations Specialist is responsible for managing Employee.
• Relations cases for designated workforce group(s). Management of Employee.
• Relations includes, but is not limited to, assistance with complex employment policy interpretation, workforce grievances, advice of management on discipline.

Location: Latina and sometime Pomezia (RM)

We offer: We offer a 6 month fixed term contract with the possibility of both personal and professional growth.
Level and salary will be adjusted according to the candidate's experience.

Responsabilities:

• supports Labor / Employee Relations Cluster Leader to provide a high level of service to employees, HR Community and Business Leaders.
• works closely with HR business partners and relevant stakeholders on all employee and labor relations topics.
• serves as the first line contact to human resources by providing guidance and assistance to employees for policy inquiries and employee related issues.
• provides employee relations support, including conflict resolution, disciplinary action, and performance improvement counseling.
• communicates policy updates and changes to HR Council, business and employees.

Requirements:

• law degree;
• previous knowledge of Employment and Labor Relations laws, regulations and practices is considered a plus;
• proficient in English (experience of HR activities managed in english, i.e.: conf call;
• training, written communications etc...);
• very good knowledge of MS office tools and platforms University;
• good logical and tactical thinking;
• strong communication skills.

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Randstad Italia spa Specialty Pharma ricerca per strutturata multinazionale farmaceutica un tecnico di laboratorio.

Sede di lavoro: Roma

Si offre: contratto di somministrazione iniziale a tempo determinato con possibilità di crescita personale e professionale, e livello da definire sulla base della reale esperienza del candidato.

Mansioni:

• controllo qualità dei reagenti e dei campioni;
• gestione e verifica della strumentazione di laboratorio;
• registrazione delle attività secondo le GMP.

Requisiti richiesti:

• laurea in discipline scientifiche;
• pregressa esperienza di almeno 6 mesi e conoscenza delle tecniche di calibrazione e manutenzione della strumentazione di laboratorio.

L’attenzione ai dettagli e la capacità di operare sotto stress completano il profilo.

 

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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

In collaborazione con Azienda farmaceutica che produce e commercializza prodotti sterili e liofilizzati, siamo alla ricerca per il plant di Ferentino (FR) di due risore:

2 ANALISTI/E DI LABORATORIO CHIMICO (QC)

Si richiede disponibilità immediata e flessibilità a lavorare su turni.

Contratto: diretto con l'azienda, il livello di inquadramento verranno commisurati all'esperienza del candidato.

Responsabilità:

• Esecuzione di test qualitativi e quantitativi per le analisi di materie prime e prodotti finiti.
• Attività analitica relativa ad analisi in process, prodotti bulk ed utilities.
• Attività analitica relativa a studi di stabilità ed analisi di rilascio.
• Attività analitica relativa a convalide analitiche e transfer con i Clienti.
• Utilizzo delle principali tecniche di laboratorio e strumentazione di laboratorio chimico.
• Compilazione e gestione della documentazione analitica.

Requisiti:

• Laurea ad indirizzo scientifico (CTF, Chimica, o similari).
• Buona conoscenza della lingua inglese.
• Almeno 1/2 anni di esperienza nella mansione.
• Buona capacità di lavorare in team.
• Buona capacità di organizzazione del proprio lavoro.

 

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Employer: GN Group

The GN Group will soon be launching their Graduate Programs which will be open to 15 recent graduates in the fields of Engineering, Finance, Marketing, Information Technology, Supply Chain and Business.

It offers you a unique opportunity to make a true difference in people’s everyday lives. As a GN Graduate you will experience a great network of peers, a steep learning curve, management exposure, and get a unique opportunity to develop personal and professional skills in a global setting.

Our long-term plans include you!

Apply for one of our six tracks:

1. Engineering
2. Finance
3. Marketing
4. IT
5. Supply Chain
6. Business

How it works?
We offer a two-year cross-functional program with 3 rotations of eight months duration. You will spend the 2nd rotation abroad in one of our many subsidiaries around the globe.
You will get included as every other employee in the company and you will work on your own projects during each rotation. As you are considered to be an employee you will be paid a full time salary with pension and other benefits.
During the 2 years that the program lasts, you will be prepared for a career in GN, and we will support you in finding a position in the company during your third rotation.

When does the Graduate Program start?
The recruitment window will open from October 2024, the Graduate Program will start on September 1^st 2025.

For foreign students:
We are a multi-cultural and inclusive company, so the only language we require is English.
And even though you are still on your Master, we hope to get an application from you, so you can start your career with us when you finish your education.

Further information: 
https://www.gn.com/Working-with-us/Graduate-Program

⚠️ To submit your application, please go to the following site:
https://www.gn.com/Working-with-us/Graduate-Program

-

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Randstad In House Specialty Pharma ricerca per importante azienda cliente un operatore farmaceutico per l’area di preparazione materiali.
La risorsa sarà inserita nel reparto produttivo connesso alla successiva area del rifornimento delle pompe che iniettano la soluzione farmacologica nell'area del riempimento di blister e contenitori farmacologici.

Sede di lavoro: Modugno (BA)

Si offre: contratto in somministrazione di 3/6 mesi con possibilità di proroghe ed opportunità future di crescita personale e professionale.
CCNL Chimico Industria livello E3.

Mansioni:

• preparazione dei materiali attraverso la sterilizzazione, il lavaggio e l’asciugatura degli stessi;
• carico manuale e spostamento delle attrezzature e loro approvvigionamento;
• elaborazione reportistica e compilazione batch record e documenti di produzione.

Requisiti richiesti:

• laurea in Tecnologie Chimiche e Farmaceutiche, Chimica, Farmacia;
• buona padronanza della lingua inglese;
• la conoscenza delle GMP e una pregressa esperienza nel settore farmaceutico costituirà titolo preferenziale;
• disponibilità a lavorare su tre turni (6/14, 14/22, 22/6) dal lunedì alla Domenica, con giornate di riposo compensativo.

Dinamicità, capacità organizzative ed orientamento al team working completano il profilo.

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Employer: Novo Nordisk Engineering (NNE)

Does the idea of being at the forefront of commissioning and qualification for cutting-edge pharma facilities excite you? Are you passionate about ensuring the smooth and safe installation and qualification of high-tech equipment in a dynamic project-based environment? If so, we have a job opportunity for you!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Virum

The Role & Department
We are looking for a Commissioning & Qualification (C&Q) Engineer to join our team, focusing on ensuring the successful installation, commissioning, and qualification of equipment and systems. As a C&Q Engineer at NNE, you will be involved in the critical stages of site commissioning where you will plan, coordinate, and execute work related to the installation and testing of equipment and systems.

Our team ensures high-quality project execution in a collaborative and safe working environment. We are dedicated to helping our customers automate their facilities and implement state-of-the-art technology.

Responsabilities
As a C&Q Engineer, you’ll:

• Review and follow-up on detailed plans from the installation of equipment and systems to mechanical completion and through the first dynamic testing and commissioning activities.
• Systemize and mark up P&IDs for various pre-commissioning activities (boundary drawings).
• Ensure smooth communication and planning between stakeholders on-site through regular meetings.
• Follow up on outstanding issues and monitor the progress and quality of C&Q activities.
• Provide guidance and support related to C&Q to colleagues, management, and other stakeholders.
• Maintain a high focus on Health, Safety, and Environmental (HSE) aspects to ensure a safe working environment for yourself and your colleagues.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• Are agile and able to prioritize urgent tasks while maintaining quality standards.
• Have a solution-oriented mindset and are always keen to improve processes.
• Are a good listener and respectful of individual and cultural differences among colleagues.
• Take initiative and actively work towards improving C&Q processes based on your experience.
• Are highly collaborative and enjoy working in team-based environments.
• Are mindful of your surroundings and able to flag concerns when necessary.

We believe these qualifications are needed for you to do well in this role:

• A degree in engineering (mechanical, process, or related field) or marine engineering ("maskinmester").
• Knowledge of project management, risk assessment, and quality assurance.
• Fluent in both Danish and English (written and spoken).

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Array ( [id] => 1313 [azienda_id] => 208 [lauree] => {90} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1728565443 [title] => Informatore scientifico del farmaco [body] =>

Randstad Italia, Specialty Pharma, ricerca per una grande realtà del settore farmaceutico Informatori Scientifici del Farmaco.

Territorio di competenza: Roma e Provincia

Contratto: La forma contrattuale, la sua durata ed il livello di inquadramento saranno commisurati alla reale esperienza del candidato.

Mansioni:

• pianificazione ed esecuzione di visite nella zona assegnata;
• presentazione efficace dei prodotti farmaceutici, evidenziandone le caratteristiche, i benefici e le modalità d'uso;
• gestione delle relazioni con i professionisti sanitari, instaurando un rapporto di fiducia e collaborazione;
• partecipazione a congressi, convegni e eventi scientifici per rimanere aggiornato sulle novità del settore;
• monitoraggio del mercato farmaceutico e della concorrenza, riportando le informazioni rilevanti al team;
• gestione accurata della documentazione relativa all'attività svolta.

Requisiti richiesti:

• laurea in discipline scientifiche idonee allo svolgimento della professione
• ottime capacità comunicative e relazionali, unite ad una spiccata propensione al contatto con il pubblico;
• forte orientamento al risultato e al raggiungimento degli obiettivi aziendali;
• capacità di lavorare in autonomia e di gestire efficacemente il proprio tempo;
• interesse per il settore farmaceutico e per l'informazione scientifica;
• buona conoscenza della lingua inglese e dei principali strumenti informatici.

Non è richiesta una pregressa esperienza nel ruolo, ma costituirà titolo preferenziale aver maturato anche brevi esperienze nel settore farmaceutico o in ruoli commerciali a contatto con il pubblico. Valutiamo con grande interesse anche giovani laureati desiderosi di intraprendere una carriera come Informatore Scientifico del Farmaco.

 

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In Bristol Myers Squibb, siamo ispirati da un'unica visione: trasformare la vita dei pazienti attraverso la scienza. In oncologia, ematologia, immunologia e malattie cardiovascolari - una delle pipeline più diversificate e promettenti del settore - ciascuno dei nostri colleghi contribuisce con passione alle innovazioni che guidano un cambiamento significativo. Diamo un tocco umano a ogni trattamento di cui siamo pionieri. Unisciti a noi e fai la differenza.

Il candidato scelto per lo Stage CURRICULARE in PROCUREMENT vedrà l’assegnazione di un progetto formativo e qualificante, inserito in un team dinamico che ha costanti interazioni con i team Global e sarà, seguito da un Tutor senior

Il candidato acquisirà:

• Conoscenze fondamentali del Procurement applicato al marketing operativo nel mercato farmaceutico e avrà la possibilità di sviluppare le competenze analitiche necessarie per svolgere le suddette attività;
• Competenze a abilità a svolgere attività in team e in organizzazioni internazionali a matrice complessa;
• Competenze sulla gestione dei rapporti commerciali con i fornitori e capacità di selezionare le migliori soluzioni a supporto dei progetti marketing dell’azienda.
• Competenze e abilità sul project management e analisi dei rischi

Il candidato/a ideale avrà le seguenti caratteristiche:

• Prossimo conseguimento della Laurea (Magistrale o Specialistica – 5 anni) in Discipline Scientifiche o Economiche;
• Ottima conoscenza della lingua inglese;
• Ottima conoscenza del pacchetto Office, utente avanzato di Excel e Power Point;
• Capacità di analisi, con un'attenzione particolare ai dettagli, eccellenti capacità organizzative e capacità di riconoscere le priorità;
• Self-starter e veloce, con la capacità di svolgere attività in modo indipendente e di lavorare in team cross-funzionali;

Sede: Roma

 

 

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Array ( [id] => 1236 [azienda_id] => 216 [lauree] => {85}{67}{83}{68}{91}{77}{86} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1727421141 [title] => Scientist, Manufacturing [body] =>

Employer: AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.  

Location: Copenhagen, Denmark

The Role & Department
Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.  

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Array ( [id] => 1268 [azienda_id] => 230 [lauree] => {59}{60} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1728380474 [title] => Regulatory Affairs – Promo & Congresses (Internship) [body] =>

Place of work: Pisa 

Type of contract: internship (onsite position)
Possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

• Manage promotional materials: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns.
• Collaborate with cross-functional teams: work closely with marketing, medical, and legal teams to align promotional strategies with regulatory guidelines, ensuring that messaging is accurate, compliant, up-to date and sufficiently complete.
• Liaise with regulatory authorities: be responsible for submitting promotional materials to regulatory bodies for review, addressing any feedback or required modifications to ensure timely approval and market readiness.

What are the requirements?

• Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
• Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
• Ability to work in a team and aptitude for learning.

What we offer?

• Dynamic and challenging work environment with international projects.
• Ongoing training and opportunities for professional growth.

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Array ( [id] => 1263 [azienda_id] => 177 [lauree] => {59}{60} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1727937402 [title] => Farmacisti [body] =>

La Divisione LifeScience di Gi Group, prima multinazionale italiana del lavoro, è specializzata nella Ricerca e Selezione di profili specializzati nei settori Farmaceutico e Medicale e nella Ricerca e Selezione di Ottici e Farmacisti per i canali Retail/GDO.

Il nostro cliente è una società attiva nel settore della grande distribuzione, per te un’opportunità come:

FARMACISTA

La risorsa sarà inserita nella parafarmacia all'interno del punto vendita, in un contesto sicuro, con orari di lavoro su turni continuanti esclusivamente diurni e definiti.

Sedi: varie città in Italia.

Contratto: Tempo determinato ed indeterminato

Responsabilità:

• Servizio di assistenza e consulenza specialistica qualificata alla clientela per i prodotti OTC, SOP, integratori, omeopatici e dermocosmesi;
• Gestione cassa e ordini
• Riordino dei prodotti in vendita

Siamo interessati a valutare risorse motivate al trasferimento, il cliente offre un contributo economico per i primi 6 mesi di contratto.

Requisiti:

• Laurea in Farmacia o in Chimica e Tecnologie Farmaceutiche
• Iscrizione all’Ordine dei Farmacisti
• Spiccate doti comunicative e relazionali, orientamento al raggiungimento di obiettivi

Valutiamo candidati/e neolaureati non ancora in possesso di abilitazione, per un iniziale inserimento come addetti/e alle vendite in attesa dell’avvenuta iscrizione all’Ordine.

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Array ( [id] => 1282 [azienda_id] => 216 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1728391578 [title] => IT Validation Engineer - NNE [body] =>

Employer: Novo Nordisk Engineering (NNE)

Does the idea of working with validation of complex data engineering solutions excite you? And do you thrive on close collaboration with great colleagues? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Virum or Kalundborg

The Role 

We are looking for a Validation Engineer to join our team of highly skilled colleagues in Manufacturing Intelligence. As a team, we are working on providing full-service intelligence solutions for pharma manufacturing, covering all aspects of data engineering and science, including cloud deployment, app development, data implementation, data management, GxP validation, and advanced analytics.

We specializes in data connectivity solutions that enable data-driven decision-making, process automation, and faster access to critical production data.

Why do we need you? Our goal is to grow our Danish team providing our customers with skilled resources for their projects and strategic challenges. Your role will be key in developing solutions for customers, ensuring proper testing and documentation of solutions, and continuously give input to our department’s skillset and delivery models.

Responsabilities
As an IT Validation Engineer, you’ll be:

• Part of setting the standard for testing and qualification of the developed solutions
• Coordinating with engineers across disciplines in close collaboration with our customers
• Participate in IT risk assessments and requirement setting
• Monitoring the quality of the validation work and supporting engineers during test activities
• Working with Science and Risk based validation with high focus on quality of data and data integrity

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• Enthusiastic about IT and data quality and interested in learning
• Outgoing who actively seek advice and share knowledge among colleagues and peers
• Result-oriented and have a well-structured work ethic
• Efficient and keep your promises and deadlines
• Comfortable with direct Customer interaction and relationship building

In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role:

• Experience in the Lifesciences and/or Biotech Industry preferably particularly in Commissioning, Qualification and Validation of automation systems, software, or IT
• Have worked with GAMP5, SRV, IT risk assessments and GMP test documentation is an advantage
• Knowledge of/or experience working with MS Azure DevOps or eTIMS (HP ALM)
• Knowledge of/or experience in basic coding languages, markdown editing etc
• You have a degree in engineering or other relevant work experience
• You speak and write English fluently and optionally Danish

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Location: Home-based Italy (preferred big and well-connected cities)
Work mode: Ability to manage required travel of up to 75% on a regular basis
Contract: Permanent

Job summary:
The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Requires guidance and oversight, while developing an understanding of the drug development and commercialization process.

Job responsabilities:

➤ Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

➤ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

➤ For the Clinical Monitoring/Site Management Plan (CMP/SMP):

• Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Verifies site compliance with electronic data capture requirements.

➤ May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 

➤ Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

➤ Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. 

➤ For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. 

➤ May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. 

➤ Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. 

➤ Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

➤ For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:

• Site support throughout the study lifecycle from site identification through close-out.
• Knowledge of local requirements for real world late phase study designs.
• Chart Abstraction activities and data collection.
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff.

What we’re looking for:

➤ CRA certification according to Ministerial Decree 15 Nov 2011.
➤ Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
➤ Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
➤ Must demonstrate good computer skills and be able to embrace new technologies.
➤ Excellent communication, presentation and interpersonal skills.

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AURORA BIOFARMA, importante azienda farmaceutica in forte espansione a livello nazionale ed internazionale con sede a Milano, titolare di farmaci in fascia A, dispositivi medici e integratori alimentari sta ricercando, per il potenziamento della propria rete, Informatori Scientifici del Farmaco su tutto il territorio italiano.

Ruolo: Informatore Scientifico del Farmaco

Sede: su tutta Italia
Contratto: contratto autonomo a Partita IVA in monomandato.

I candidati ideali sono:

• Laureati in discipline scientifiche con titolo di studio idoneo (Dlgs 219/2006) o titolo equipollente o esperienza pregressa.
• Orientati al lavoro per obiettivi e disponibili a lavorare sul territorio assegnato.

Competenze e capacità richieste:

• Motivazione, proattività e orientamento al raggiungimento dei risultati.
• Saper costruire relazioni professionali di valore e interpersonali.
• Capacità organizzativa e autonomia.
• Solide conoscenze scientifiche di base.
• Utilizzo dei dispositivi elettronici come PC e tablet, sistemi informatici e database aziendale.
• Patente di guida B ed automuniti.

Offerta aziendale:

• Materiale promozionale e supporto formativo continuo in sede e sul campo.
• Provvigioni tra le più elevate del settore ed incentivi.
• Concrete opportunità di crescita professionale.
• Politiche commerciali stimolanti e meritocratiche.
• Auto aziendale su richiesta

Nella cover letter specificare per quale area geografica ci si candida.

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Employer: Novo Nordisk Engineering (NNE)

 Does the idea of being a part of a team of MES (Manufacturing Execution System) engineers, working on Danish production sites with our customers, appeal to you?
Do you thrive on the possibility of creating new solutions in our MES system running in a complex production environment? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg

The Role & Department
In our department we work with Manufacturing Execution Systems (MES), and our team of multidisciplinary IT engineers are working on both upstream and downstream processes within pharma and biotechnology. All our work is project-based, which means that with every new project, you’ll develop your competencies further.
Please notice, that this role requires you to mostly be on location at our customers in Denmark, Kalundborg.

Responsabilities
As a MES Engineer, you’ll be:

• Working side by side with innovative colleagues.
• Advising clients on how to maximize the benefits of our MES System.
• Gathering technical requirements through a variety of techniques (e.g., facilitated workshops, work sessions, interviews and technical analysis).
• Ensuring that workflows / recipes are successfully designed and developed in line with site business processes and technical standards.
• Commissioning and undertaking test and qualification of IT systems in manufacturing environments.
• Estimating and coordinating own tasks.
• Working closely with our customers on site.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

• A team-oriented person, curious and eager to learn.
• Understanding of your colleagues’ individual and cultural differences.
• Aware of your surroundings and able to flag any concerns.
• Agile and able to prioritize urgent tasks.
• Excited to build on the NNE culture of innovation.

We believe these qualifications are needed for you to do well in this role:

• Either an engineering, computer scientist or similar degree or having pharmaceutical production experience.
• Experience with MES systems like Körber PAS-X, Emerson Syncade or NNE LMES.
• Experience from Pharma/Regulated business (not a requirement).
• You speak and write Danish and English (Danish not a requirement but recommended).

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be a part of an engineering team in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products, you will also have every opportunity to develop and grow your own skills.   

Every two seconds, products from Ferrosan Medical Devices help surgeons and nurses around the world to control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team! 

Joining us at our HQ in Søborg, Denmark, you will become an integral part of our Technology Innovation department, consisting of 20 highly specialized engineers and pharmacists. You will be a part of the Technology Innovation external team dividing your time between operational tasks, ensuring our outsourced production runs smoothly, and play an important role in our development projects. 

Responsibilities
More specifically, you will be spending a great deal of your time working closely with our sub-suppliers of injection moulding, handling the challenges and obstacles that may occur during production.
Doing so, you can look forward to:

• Supporting our sub-suppliers, ensuring that we can deliver and keep our production running.
• Participating in projects, design workshops, and cooperating with stakeholders across our organization.
• Establishing and maintaining documentation packages, and life-cycle management of our components.
• Overseeing and giving input to validation activities carried out by suppliers.
• Implementing changes and improvements through our change control system.

Your profile
As a person, you are a team player, and you are skilled in keeping an overview of your tasks. 
You are quality-conscious, and you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments.
You thrive in a high pace environment.
You have a solid data-based approach to your work, and you understand the importance of documentation and processes. At the same time, you thrive when interacting with a range of different people.
You have the skills to communicate and convey technical matters into more tangible formulations.
Your language proficiency in both written and spoken English is at a professional level as many of your tasks will be executed in collaboration with English speaking colleagues. 

Qualifications
Ideally, you hold an Engineering degree and experience with injection moulding, plastic production and technical projects.

Other relevant qualifications are:

• Experience with production – preferably from a similar industry (medtech/pharma/food).
• Experience with project management.
• Experience with and understanding of GMP, process risk management, validation, and qualification of production processes.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partnership con tra le migliori aziende cosmetiche italiane del make e skincare, eccellenza del made in Italy, offriamo un'interessante e stimolante opportunità in ambito:

Controllo Qualità Bulk

Sede: provincia di Bergamo

Orario di lavoro: tre turni.

Responsabilità:

• Esegue le analisi chimico-fisiche e organolettiche del bulk secondo le specifiche (presenti in Rete e prodotte dalla ricerca) e secondo le priorità assegnate.
• Approva e permette lo scarico del bulk quando il prodotto è conforme alle specifiche.
• Se il prodotto è fuori specifica, fornisce alla produzione dei metodi per correggere la formula solo nel caso di piccole variazioni. Per modifiche più importanti chiede il supporto alla Ricerca.
• Produce il certificato di analisi (ok colore) dove sono presenti i dati analitici e di controllo colore (di processo), che viene inviato al cliente.
• Effettua controlli “for cause” a supporto delle indagini per produzioni non conformi.

Requisiti:

• Diploma chimico o scientifico;
• Disponibilità su tre turni;
• Saper utilizzare sistemi gestionali/ERP;
• Conoscenza dei prodotti cosmetici (anidri, emulsioni e polveri);
• Conoscenza delle principali tecniche analitiche del controllo dei prodotti cosmetici;
• Conoscenza delle tecnologie produttive dei prodotti cosmetici;
• Conoscenze delle norme di buona fabbricazione (GMP).

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Ruolo: Commissioning & Qualification Intern

Sede: Latina
Contratto: iniziale stage extracurriculare trimestrale, finalizzato ad assunzione in apprendistato.

Disponibilità: Immediata

S4BT è un’Azienda di oltre 80 specialisti e specialiste, che da oltre 25 anni fornisce Soluzioni Software e consulenze per il settore Life Science e non solo in ambito Quality Assurance, Engineering, Project Management, Validazioni, Tech Transfer, Convalide e altro.

A supporto della crescita aziendale, ricerchiamo giovani neolaureati/e che, affiancati/e ad un tutor, intraprenderanno un percorso formativo che li porterà a ricoprire il ruolo di Commissioning & Qualification Intern all’interno del gruppo Quality & Operation.

Cosa ci piace in un/a candidato/a?

• L’approccio da vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro.
• La curiosità, l’entusiasmo e l’energia.
• La ricezione di fronte alle linee guida aziendali.
• La partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Cosa richiediamo?

• Laurea in materie tecnico-ingegneristiche (es. Ingegneria Chimica, Chimica, Chimica Industriale, Chimica e Tecnologie Farmaceutiche, Biotecnologie, Ingegneria Meccanica, Ingegneria dei Sistemi e dell’Automazione).
• Buona conoscenza della lingua Inglese sia scritta che parlata.
• Buona conoscenza del pacchetto Office.
• Interesse e curiosità nelle qualifiche di equipment, ambienti ed utilities, dedicati alla produzione chimico-farmaceutica.
• Interesse e curiosità in ambito Quality Assurance and Compliance.

Cosa imparerai?

• Avrai l’opportunità di intraprendere un percorso formativo su attività di progetto di Commissioning & Qualification, all’interno del gruppo Quality and Operation.
• Offrirai supporto alle attività di Commissioning & Qualification, Quality Assurance and Compliance.

Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi. 

Se ti interessa la posizione vieni a conoscerci a Roma, il 29 ottobre 2024!

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Randstad InHouse Specialty Pharma ricerca per importante azienda cliente operante nel settore farmaceutico un Quality Assurance.

Sede di lavoro: Modugno (BA)

Si offre: contratto full-time in somministrazione, per un periodo iniziale di 12 mesi e successive possibilità di crescita personale e professionale. Il livello di inquadramento e la RAL saranno determinati sulla base della reale esperienza del candidato.

Mansioni:

• verifica della completezza e accuratezza del piano di monitoraggio microbiologico delle aree classificate;
• identificazione delle aree di miglioramento e dei trend di contaminazione in cleanroom, e analisi dei dati di monitoraggio;
• coordinamento delle indagini di superamento dei limiti definiti per la contaminazione delle aree classificate delle linee produttive e dei locali a servizio delle stesse ;
• aggiornamento continuo ed esecuzione di training sugli standard regolatori relativi al monitoraggio microbiologico ambientale e al Quality Manufacturing;
• redazione di risk assessment e report di qualifica microbiologica delle aree classificate;
• creazione e modifica della documentazione necessaria alla garanzia dello stato di compliance rispetto alle cGMP;
• implementazione di best-practices per il continuous improvement;
• interazione e presentazione dei dati agli stakeholder del processo interni ed esterni, incluse le agenzie regolatorie;
• supporto alle attività in campo (shop floor) per la valutazione di condizioni anomale.

Requisiti richiesti:

• laurea in Biologia, Biotecnologie, Chimica e Tecnologie Farmaceutiche o affini;
• esperienza in ambito Quality o Sterility Assurance in aziende operanti nella produzione farmaceutica sterile in clean room o isolatore;
• conoscenza delle GMP, e del nuovo Annex 1 Eudralex;
• conoscenza delle principali tecniche di analisi del rischio;
• ottima conoscenza della lingua inglese;
• ottima padronanza degli strumenti di Office quali Word, Excel, Power-Point.

Completano il profilo ottime capacità relazionali e di negoziazione, precisione, predisposizione all’apprendimento, buona attitudine al lavoro documentale, familiarità con i sistemi computerizzati per l’utilizzo dei software aziendali dedicati (SAP, Lims, Trackwise) e disponibilità a svolgere lavoro in orario straordinario e su turni.

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Il Gruppo Servier Italia ricerca Informatori Scientifici del Farmaco che, riportando all'Area Manager, dovranno assicurare regolari contatti e visite verso i medici di Medicina Generale e Medici Specialisti dell'Area assegnata.
 
Requisiti:

• Laurea in Discipline Scientifiche (Scienze Biologiche; Chimica (indirizzo organico o biologico); Farmacia; CTF; Scienze Naturali; Diploma di laurea in Informazione Scientifica del Farmaco ecc.)
• Esperienza: almeno 6 mesi nel ruolo
• Buona conoscenza della lingua inglese
• Ricerchiamo candidati con forte entusiasmo, curiosità, intraprendenza, empatia, capacità relazionale. Desiderio di crescere nel ruolo di ISF.
   

L'azienda offre:

• Un contratto iniziale in somministrazione a tempo determinato della durata di 12 mesi con prospettive concrete di inserimento.
• Alta formazione professionale iniziale e successiva
• Grandi opportunità di crescita e di sviluppo professionale.
• Auto aziendale, tablet ed altro.

 

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Randstad InHouse, Specialty Pharma, ricerca per importante azienda cliente operante nel settore cosmetico addetti al controllo qualità per l’area bulk release.

Sede di lavoro: Olgiate Comasco (CO)

Si offre: iniziale contratto in somministrazione di 6 mesi con possibilità di proroghe ed opportunità di crescita personale e professionale.
CCNL Chimico Industria, livello e retribuzione saranno stabiuliti sulla base della reale esperienza del candidato.

Mansioni:

• controllo in ingresso e periodico delle materie prime, del semilavorato e del prodotto finito nel rispetto delle normative GMP;
• esecuzione analisi organolettiche (odore, colore, aspetto) e delle misurazioni di viscosità, pH, densità;
• valutazione dei risultati in caso di non conformità; apertura di rapporti di non conformità (OOS) e gestione dei reclami ai fornitori;
• gestione ed emissione dei certificati di analisi interni e controllo e gestione dei certificati di analisi dei fornitori;
• supporto ai reparti produttivi nel corso del ciclo produttivo;
• collaborazione continua con gli altri reparti aziendali (produzione, R&D, procurement, ufficio acquisti, qualità).

Requisiti richiesti:

• diploma di perito chimico od affini, o laurea triennale in discipline scientifiche;
• buona padronanza della lingua inglese;
• esperienza anche breve in aree di laboratorio c;
• padronanza nell’utilizzo dei seguenti strumenti di analisi: viscosimetri e reometri, densimetri, pHmetri, titolatori, termobilance, HPLC e GC;
• disponibilità al lavoro su tre turni (6/14, 14/22, 22/6) dal Lunedì alla Domenica con riposi compensativi ed alla reperibilità.

Capacità del rispetto di tempi e metodi e di operare sotto stress, attenzione e precisione completano il profilo.

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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partership con una tra le migliori aziende cosmetiche italiane del make-up e skincare, eccellenza del made in Italy, offriamo un'interessante opportunità in ambito:

ASSICURAZIONE QUALITA'

Sede di lavoro: provincia di Bergamo

Contratto: stage di 6 mesi, retribuzione 800 euro al mese, mensa, scopo assunzione.
Orario di lavoro: 8:00-16:30 con flessibilità fino a 9:15-17:45

Requisiti:

• Laurea in ambito scientifico.
• Conoscenza lingua inglese livello B2.
• Passione per la cosmesi.

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