, including generating validation plans, protocols, and reports. Qualify and optimize processes and tooling through IQ/OQ/PQ...
IQ/OQ/PQ. Configure MES platforms, troubleshoot batch issues, and integrate MES with ERP, LIMS, QMS, and historian...
and document GCC and performance qualification (PQ) activities in BRIQS, ensuring protocol adherence, traceability...
IQ/OQ/PQ. Configure MES platforms, troubleshoot batch issues, and integrate MES with ERP, LIMS, QMS, and historian...
, validations (IQ/OQ/PQ), and change control. Provide hands-on support for line issues, root‑cause investigations, and CAPA...
, etc.). Process validation & documentation Assist with process validation activities (IQ/OQ/PQ) for new molds, tooling changes...
. Develop and execute validation protocols (IQ/OQ/PQ) for laboratory instruments, equipment, and systems. Collaborate.... Strong understanding of regulatory requirements (GxP). Previous experience in equipment validation, particularly IQ/OQ/PQ processes...
assessments, URS, IQ/OQ/PQ, deviations, reports. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA...
/OQ/PQ methodologies and equipment qualification best practices. Experience working in regulated environments under FDA...
all quality requirements, including PPAPs, Validations (IQ, OQ, PQ), complaints, SCARs, CARs, on-site audits, and product quality...