QA Qualification and Validation Expert | Biologe (m/w/d)

Job Summary

This Expert role in QA Operations Qualification involves the planning, monitoring, and active participation in qualification and Computer System Validation (CSV) projects specifically for the Pfaffenhofen site. Day-to-day responsibilities include contributing to the qualification of facilities, equipment, utility systems, and analytical devices, as well as the validation of software and computerized systems according to rigorous guidelines (e.g., EU GMP Annex 11/15, 21 CFR Part 11, GAMP5). A core function is the creation, review, and release of critical documentation such as User Requirement Specifications (URS), risk analyses, validation plans, and test documents, ensuring the continuous maintenance of the qualified/validated status. The ideal candidate holds a scientific degree and ideally possesses three years of practical QA experience in a GMP-regulated setting, bringing strong knowledge of relevant national and international regulations. This position offers the opportunity to ensure regulatory compliance and high quality standards within a leading pharmaceutical company dedicated to advancing oncology and cardiovascular care.