Quality Assurance Specialist, CMC

1 week ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Quality Assurance Specialist, CMC

Lundbeck is seeking a Quality Assurance Specialist, CMC to support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the Investigational Medicinal Product (IMP) for clinical trials.

About the Role

You will join a growing department with an exciting future ahead with expected upcoming purchase of new drug candidates. As a Quality Assurance Specialist, CMC, you will be responsible for ensuring compliance for CMC deliverables from early to late phase pipeline projects.

Key Responsibilities

  • Batch record review
  • QA assessment of deviations, change controls and laboratory deviations
  • Approval of master batch records
  • Handling complaints
  • Contribute to vendor oversight (e.g vendor re-evaluations)

Requirements

  • You hold a master's degree in pharmacy, chemistry, biology, or similar qualifications
  • Sterile and biologic manufacturing knowledge is an advantage
  • Minimum 2 years of experience in a GMP regulated environment preferably in Manufacturing, Quality Control or Quality Assurance
  • Knowledge and competencies within CMC are preferred
  • You are fluent in English

About Lundbeck

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.



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