Expert QA Operations Computer System Validation (CSV) | Biologe (m/w/d)

Job Summary

This role involves planning, monitoring, and participating in computer system validation and qualification activities and projects for the Pfaffenhofen site. The expert will support the implementation, validation, and operation of local computer-assisted systems in accordance with current regulatory requirements (EU GMP Annex 11 & 15, 21 CFR Part 11, GAMP5), including data integrity assurance. Key responsibilities include contributing to the qualification of facilities, equipment, and supply systems, as well as analytical and laboratory systems. The position requires active participation in qualification and validation projects across all phases (DQ, IQ, OQ, PQ), creating and reviewing validation documents, and ensuring compliance with regulatory requirements and internal quality standards. This role is attractive for professionals seeking to contribute to patient care through rigorous quality assurance in a global pharmaceutical company.