Senior Quality Assurance Specialist for Biologics Development

12 hours ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Lundbeck is seeking a highly experienced Senior QP Delegate to join our CMC Development QA team. This exciting opportunity will enable you to contribute significantly to the development of new innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck's clinical trials.

As a key member of our newly established QP delegate team, you will leverage your professional and personal competencies to drive the continuous improvement of QP Delegate processes. Your role will be pivotal in ensuring patient safety and GMP compliance of the IMP for clinical trials.

Key Responsibilities:

  • QP confirmation of Biologic Bulk Drug Substance and Drug Product
  • QP certification of IMP
  • QA assessment of deviations, change controls and laboratory deviations
  • Approval of master batch records
  • Handling of complaints

In this role, you will collaborate with multiple stakeholders in CMC, regulatory affairs, commercial QA etc. You will contribute to our continued development of the Quality Management System by authoring and approving SOPs governing the activities.

The ideal candidate will hold a Master's degree in Pharmacy or similar qualifications meeting the requirements of a QP Delegate. Relevant experience in biologic drug substance manufacturing and at least 5-10 years of experience in a GMP regulated area are essential. Previous experience as a QP delegate would be an asset.

Salary: We offer a competitive salary ranging from €70,000 to €90,000 per year, depending on your level of experience. Additionally, you will enjoy numerous benefits, including a comprehensive health insurance plan, pension scheme, and opportunities for professional growth and development.

We are an equal opportunities employer, committed to building a diverse and inclusive workforce. If you are passionate about delivering high-quality results and contributing to the development of innovative treatments, we encourage you to apply.



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