Qualified Person (QP) – Pharmaceutical Batch Release

About the role

Lilly is expanding its high‑tech production site in Alzey and seeks an experienced Qualified Person (QP) to ensure that every medicinal batch meets the highest quality and regulatory standards before release.

Key responsibilities

• Certify and release finished product batches in compliance with GMP, marketing authorisations and internal procedures.
• Approve batch certificates and decide on corrective actions when non‑compliance is detected.
• Oversee quality review activities for semi‑finished products and monitor imported active substances.
• Maintain up‑to‑date knowledge of technical, regulatory and scientific developments.
• Participate in the implementation of new regulations and corporate quality standards on site.

Required profile

• Qualified Person (QP) status with proven experience in pharmaceutical batch release.
• Strong understanding of GMP, regulatory dossiers and quality contracts.
• Ability to make independent decisions on batch compliance and corrective measures.
• Excellent documentation and communication skills.

Required skills

• Good Manufacturing Practice (GMP) compliance
• Quality Assurance processes
• Regulatory compliance and dossier review
• Batch certification and release procedures

What we offer

• Opportunity to work in a state‑of‑the‑art manufacturing facility.
• Collaborative environment aligned with Lilly’s values of Excellence, Integrity and Respect for People.
• Competitive compensation and benefits package.