GMP/GDP Auditor, CMC Development QA Specialist

4 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time
About the Role

We are seeking a highly skilled GMP/GDP Auditor to join our CMC Development QA team. As a key member of our team, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC.

Key Responsibilities
  • Conduct external audits of CMC vendors to ensure compliance with GMP/GDP regulations
  • Conduct internal audits of CMC to identify areas for improvement and ensure compliance with GMP/GDP regulations
  • Collaborate with multiple stakeholders in CMC and vendors worldwide to ensure seamless audit processes
  • Contribute to the continuous improvement of the audit process by authoring and approving SOPs governing activities
Requirements
  • Master's degree in pharmacy, chemistry, biology, or a similar qualification
  • At least 5 years of experience as a GMP/GDP auditor
  • Fluent in English
  • Ability to travel for on-site audits
About Lundbeck

Lundbeck is a global pharmaceutical company dedicated to improving the lives of people affected by brain diseases. We offer a collaborative and inspiring work environment, passionate colleagues, and a culture characterized by collaboration and innovation.

We are committed to building a diverse and inclusive workforce that reflects the communities we serve. If you are passionate about making a difference in the lives of people affected by brain diseases, we encourage you to apply for this exciting opportunity.



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