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.
More Jobs from Daiichi Sankyo Europe GmbH
QA Administrator - Manufacturing Solids | Gesundheitsmanager (m/w/d)
Nov 6, 2025
This role is central to maintaining strict quality assurance and regulatory compliance within the Ma...
Electrical Master / Technician (Focus on Daily Operations) | Elektrotechniker (m/w/d)
Oct 17, 2025
This role involves ensuring the continuous and safe operation of electrical systems within a major p...
QA Qualification and Validation Expert | Biologe (m/w/d)
Oct 15, 2025
This Expert role in QA Operations Qualification involves the planning, monitoring, and active partic...