Key Player in GMP Compliant Clinical Trials

4 days ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time
Job Description

Lundbeck is seeking a highly skilled Senior QP Delegate to join our CMC Development QA organization. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.

About the Role

In this exciting opportunity, you will have a significant impact on our processes and contribute to the development of new innovative treatments for brain diseases. You will work closely with multiple stakeholders in CMC, regulatory affairs, commercial QA, and other departments to ensure seamless collaboration and effective communication.

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
Requirements

To be successful in this role, you must have:

  • A Master's degree in pharmacy or similar qualifications to meet the requirements of a QP Delegate
  • Experience in biologic drug substance manufacturing
  • At least 5-10 years of experience in a GMP regulated area either in Manufacturing, Quality Control, or Quality Assurance
  • Previous experience as a QP delegate would be an asset
  • Fluency in English
What We Offer

Lundbeck offers a unique position for you to build upon your experiences and professional development. This job offers great opportunities to grow your competencies and knowledge, and to widen your duties and responsibility as you develop in the role.

Benefits

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.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@lundbeck).

The salary for this role is approximately $80,000 - $110,000 per year, depending on experience and qualifications.



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