Training and Document Specialist, Quality Assurance (QA) | Pharmakant (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This role as a Training and Document Specialist within the Marketing Authorization Holder Quality Assurance (MAH QA) department is crucial for maintaining regulatory compliance within a leading global pharmaceutical company. The specialist will be responsible for the end-to-end management of training programs, including creating and updating training plans, developing concepts (such as GMP refresher courses), and leading in-person sessions focused on QA and QM topics. A key part of the role involves extensive documentation control: reviewing, formally approving, archiving, and ensuring the periodic revision of GxP documents and instructions. Success requires a strong scientific background, ideally as a Pharmaceutical Technician or Technical Assistant, coupled with several years of experience in a GxP-regulated environment and profound knowledge of Good Manufacturing Practice (GMP). Excellent communication, persistence, and fluency in German, alongside good English skills, are essential for effective collaboration within the multinational team.
Required Skills
Education
Completed scientific training (e.g., Pharmaceutical Technician or Technical Assistant)
Experience
- Several years of professional experience in a GxP-regulated environment
- Experience in the pharmaceutical industry or comparable field
- Professional experience in developing and implementing training concepts
- Experience with monitoring and controlling QM-relevant training measures
- Experience with formal approval and archiving of GxP documents
Languages
Additional
- Not specified
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