worldwide are reliably supplied with high-quality products? In this responsible key position, you will assume the duties of a Qualified Person (QP) in accordance with the German Medicines Act and, together with internal departments and external manufacturing partners, ensure compliance with the highest quality standards.

These are your tasks

• Assumption of responsibility as a Qualified Person (QP) in accordance with the German Medicines Act (AMG), the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) and the applicable EU GMP requirements.
• Testing and certification of batches before placing on the market, as well as release of relevant quality documentation
• Evaluation of batch deviations, handling of quality-related issues and participation in recall activities
• Responsibility for Product Quality Reviews (PQRs), Quality Agreements, and the GMP-compliant storage of quality-relevant documentation.
• Supervision and monitoring of external contract manufacturers, including assuming the role of production manager within the area of ​​responsibility
• Creation and maintenance of product documentation, product specifications, approval documentation and SOPs
• Planning, execution and follow-up of GxP audits as well as consulting on the further development and assurance of a compliant quality management system
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