Qualification/Validation Specialist in Quality Assurance | Mitarbeiter (m/w/d) Qualifizierung/Validierung im Bereich Qualitätssicherheit
TYC Personalmanagement Gerlinde Tyc
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).
Required Skills
Education
Completed natural science or technical vocational training (minimum 3 years) in fields such as Pharmacy, Chemistry, Biology, or Engineering
Experience
- Professional experience in qualification and validation in a pharmaceutical GMP environment
- In-depth knowledge and experience in device qualification and Computer System Validation (CSV)
Languages
Additional
- Not specified