Quality Assurance Biologist

5 days ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time
Job Description

In this role, you will be responsible for:

  • Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.
  • Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities.
  • Reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories.
  • Collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.
  • Supporting regulatory filings and other interactions with Health Authorities.

This position requires a strong understanding of GDP/GMP guidelines, knowledge of the United States Pharmacopoeia and the European Pharmacopoeia, and experience in methods used to test biological molecules.

Additionally, you must have advanced English verbal and written communication skills and be able to work effectively in matrix teams in a fast-paced environment with changing priorities.



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