GMP/GDP Auditor, CMC Development QA Specialist

1 month 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, ensuring compliance with regulatory requirements.

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 regulatory requirements
  • Collaborate with multiple stakeholders in CMC and vendors worldwide to ensure effective audit processes
  • Contribute to the development of the Quality Management System by authoring and approving SOPs
Requirements
  • Master's degree in pharmacy, chemistry, biology, or a related field
  • At least 5 years of experience as a GMP/GDP auditor
  • Fluent in English
What We Offer

Lundbeck offers a dynamic and collaborative work environment, with opportunities for professional growth and development. As a member of our team, you will have the chance to work on exciting projects, collaborate with talented colleagues, and contribute to the development of innovative treatments for brain diseases.

We are committed to diversity and inclusion, and we welcome applications from candidates with diverse backgrounds and experiences. If you are passionate about quality assurance and regulatory compliance, and you are looking for a challenging and rewarding role, we encourage you to apply.



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