Qualified Person (QP) / Qualified Person

Do you want to take responsibility for the quality and safety of medicinal products and actively contribute to ensuring that patients 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 Medicines Act and, together with internal interfaces and external manufacturing partners, ensure compliance with the highest quality standards.

• Assumption of responsibility as Qualified Person (QP) in accordance with AMG, AMWHV and 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, processing of quality-relevant issues and participation in recall activities
• Responsibility for Product Quality Reviews (PQRs), Quality Agreements and GMP-compliant retention of quality-relevant documentation
• Support and monitoring of external contract manufacturers including assumption of the function of manufacturing management in 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 advice on further development and assurance of a compliant quality management system

• Completed pharmacy studies with approbation as a pharmacist (m/f/d) or equivalent scientific university education
• Expert knowledge according to § 15 AMG as well as several years of professional experience in the pharmaceutical industry
• Sound knowledge of relevant GMP requirements and the regulatory environment
• Experience in working with contract manufacturers, authorities and international interfaces is an advantage
• Good German and English skills in word and writing
• Confident handling of common IT applications, ideally also with SAP
• High personal responsibility, decisiveness and strong communication and consulting skills