Qualified Person (QP) – Pharmaceutical Industry

About the role

We are looking for a Qualified Person (QP) to join our team in Germany. You will work from one of our offices in Heidenheim an der Brenz, Berlin, or remotely, supporting both internal projects and external customers in the pharmaceutical sector.

Key responsibilities

• Act as the Qualified Person in accordance with §14 of the German Medicines Act (AMG).
• Monitor EU GMP status, manufacturing, and testing of medicinal products.
• Release batches for market placement, maintain release registers, and prepare annual PQRs.
• Serve as the responsible person for narcotics and manage related documentation.
• Approve qualification and validation measures.
• Conduct internal and external audits.
• Serve as the primary contact for authorities and customers on pharmaceutical and drug‑law matters.

Required profile

• Completed pharmacy studies.
• Qualified Person certification according to §15 AMG, recognized by a state authority.
• Professional experience in pharmaceutical production or testing.
• Fluency in German and English.

Required skills

• EU GMP knowledge.
• German Medicines Act (AMG) expertise.
• AMWHV familiarity.

What we offer

• Flexible working hours and location options (onsite, remote, hybrid).
• Opportunity to influence processes and work on diverse projects.
• Collaborative, inclusive culture focused on personal development.