Qualified Person (QP) in Radiopharmacy | Qualified Person (QP) in der Radiopharmazie (m/w/d)
ABX advanced biochemical compounds
Job Summary
The Qualified Person (QP) in Radiopharmacy will play a central role in ensuring the compliant release of radiopharmaceutical products for distribution, serving a global market leader in PET diagnostics. Daily responsibilities include the critical review and approval of batch protocols, analysis data, and production-relevant documentation. A core function of this role is investigating and processing deviations, implementing necessary corrective measures in the manufacturing process, and actively participating in internal and external audits of production facilities and quality systems. Furthermore, the QP will be instrumental in optimizing processes to enhance the effectiveness of the Quality Management System (QMS) and providing expert regulatory guidance to internal teams. The ideal candidate must possess a university degree in a natural science field and significant experience as a QP, ideally within radiopharmaceuticals or injectables, coupled with fluent German and English skills. This position offers a secure, long-term career path within an expanding, internationally focused pharmaceutical company.
Required Skills
Education
University degree in Natural Sciences (Chemistry, Pharmacy, Medicine, Pharmaceutical Chemistry, or Biology) or comparable field
Experience
- Professional experience as a Qualified Person (QP) according to the German Medicines Act (§14 AMG)
- Experience, ideally with radiopharmaceuticals or injectable preparations
- Several years of practical experience in the quantitative and qualitative analysis of radiopharmaceuticals
- Professional experience in pharmaceutical manufacturing, quality assurance, and regulatory requirements
Languages
Additional
- Not specified
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