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

Job Summary

This role is a crucial opportunity to join Daiichi Sankyo's Quality Assurance department, focusing on ensuring the highest standards of compliance within their European operations, headquartered near Munich. The QA Operations Expert will be responsible for the planning, monitoring, and execution of qualification and Computer System Validation (CSV) activities for the Pfaffenhofen site. Day-to-day tasks involve participating in the qualification of facilities, equipment, utility systems, and analytical/computerized lab systems, as well as validating software according to strict regulatory guidelines like EU GMP Annex 11/15, 21 CFR Part 11, and GAMP5. A significant part of the role includes generating, reviewing, and approving critical documentation such as URS, risk analyses, validation plans, and test documents. The ideal candidate possesses a scientific background, practical QA experience in a GMP environment, and strong proficiency in both German and English, contributing directly to the company's mission in oncology and cardiovascular health.