Person in charge of Qualification/Validation activities: production equipment and / or utilities & HVAC, environment, cleanroom.
- Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Qualification Master plans are up to date and established for all ongoing projects.
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification documentation).
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners.
- Coordination and oversight of external suppliers.
