1. expertise in SAP S/4HANA Quality Management (QM) processes: in-process, incoming, and final inspections; batch management; stability studies; and quality notifications.
2. Experience with Life Sciences compliance requirements (GxP, FDA/EMA, Annex 11, 21 CFR Part 11) and supporting system validation deliverables (URS/FRS, IQ/OQ/PQ).
3. Integration knowledge across QM and other S/4 modules (PP, MM, WM/EWM, SD) as well as external systems (LIMS, MES, BRH, regulatory systems).