FDA/QSR and ISO environment. Demonstrated hands-on technical aptitude. Experience in process validation (IQ, OQ and PQ...
, and execute CQV lifecycle documentation (including URS, FMEA, DQ, IQ, OQ, and PQ protocols) for clean utilities, process equipment...
/SAT, IQ/OQ/PQ), and liquid processing systems (UHT, aseptic, CIP) to support a major greenfield build of a next-generation..., commissioning, and qualification (DQ, IQ, OQ, PQ) Participate in FAT/SAT, performance testing, and startup troubleshooting Support...
with risk assessments/procedures for new facility. Reading & review of EM plates. Execution of EM PQ of new facility...
, validation and qualification activities (IQ/OQ/PQ), and technical investigations, while driving continuous improvement..., and/or processes;supports vendor and site acceptance testing as required. Leads and/or supports validation activities (IQ/OQ/PQ...
. Review, approval and execution of commissioning and qualification activity including FAT's/SAT's IQ/OQ/PQ's. Support NPI...
validation (IQ/OQ/PQ) advantageous. Strong people leadership and team-building skills. Decisive, with the ability to prioritise...
Qualif ication (OQ), and Perf ormance Qualif ication (PQ). Team Leadership & Development Lead, mentor, and develop a team...
and execution of Validation Plans, IQ/OQ/PQ protocols, and Summary Reports. Drive and implement system-related improvements...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Develop, execute, and report... validation including IQ, OQ, and PQ execution. Experience with packaging development, packaging validation, and integration...