Scientist, QA Manufacturing Support

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.