QA Operations Representative, Fill & Finish / Packaging | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This QA Operations Representative role focuses on ensuring strict GxP compliance within the Fill & Finish and Packaging areas at the Pfaffenhofen site for a leading pharmaceutical company dedicated to oncology and cardiovascular health. Key daily responsibilities include the controlled provision, management, and comprehensive review of batch documentation, including final QA sign-off for product release. The representative will also be responsible for organizing documentation for audits and inspections, conducting GxP-relevant training for QA operations staff, and supporting the creation and revision of Standard Operating Procedures (SOPs). Candidates must possess a Master’s degree in a natural science field (e.g., Biology or Biotechnology) and demonstrable professional experience in a GxP-regulated pharmaceutical environment, particularly practical experience reviewing batch records and audit trails. This position offers the opportunity to drive quality standards and directly support life-enriching therapies.
Required Skills
Education
Master's Degree in Natural Sciences (e.g., Biotechnology, Biology, Process Engineering)
Experience
- Professional experience in a GxP-regulated environment, ideally in the pharmaceutical industry
- Practical experience in conducting documentation reviews, especially batch documentation and audit trails
- Foundational knowledge of national and international pharmaceutical law (e.g., AMG, AMWHV, EU GMP)
Languages
Additional
- Role is based at the Pfaffenhofen, Germany location.
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