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

Job Summary

As a QA Operations Qualification Expert at Daiichi Sankyo, you will play a critical role in ensuring that all facilities, equipment, and computerized systems at the Pfaffenhofen site meet stringent regulatory and internal standards. Your daily responsibilities include overseeing qualification phases (DQ, IQ, OQ, PQ), drafting and approving essential documentation like User Requirement Specifications (URS) and risk analyses, and ensuring compliance with EU GMP Annex 11/15 and GAMP5 guidelines. You will act as a key liaison for production, quality control, and engineering departments, managing deviations and change requests to maintain a GxP-compliant environment. This position is ideal for a detail-oriented professional looking to contribute to a global healthcare leader focused on oncology and cardiovascular therapies. The role offers a unique opportunity to work in a highly regulated, innovative environment where your expertise directly impacts patient safety and product quality through rigorous quality assurance and validation processes.