Qualification/Validation Specialist in Quality Assurance | Mitarbeiter (m/w/d) Qualifizierung/Validierung im Bereich Qualitätssicherheit

Job Summary

This role supports the Quality Management department of a global pharmaceutical company in Pfaffenhofen an der Ilm, focusing on qualification and validation within new construction projects. The specialist will be crucial in reviewing and creating essential documentation such as User Requirement Specifications (URS), risk analyses, and Validation Master Plans (VMPs). A key part of the job involves examining and approving qualification and validation documents (DQ, IQ, OQ, PQ) and contributing to the validation of software and computer-based systems in line with GxP, 21CFR11, and GAMP5 guidelines. The ideal candidate will ensure strict adherence to regulatory requirements and high-quality standards within a GMP pharmaceutical environment, bringing strong expertise in device qualification and Computer System Validation (CSV).