Director, Quality
Management (SQM), including qualification, auditing, scorecards, and risk mitigation. Validate manufacturing processes (IQ/OQ/PQ...
Management (SQM), including qualification, auditing, scorecards, and risk mitigation. Validate manufacturing processes (IQ/OQ/PQ...
, Root Cause problem solving techniques) Knowledge on Product, equipment validation (IQ, OQ, PQ) Preferred Skills...
Qualification (PQ). Serve as a subject matter expert (SME) in advanced manufacturing technologies such as laser processing...
, procedures) Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.) Prioritize...
in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software...
(IQ/OQ/PQ as applicable) for computerized systems, equipment, utilities, and environmental systems;ensure protocol... and various quality systems Knowledge of cGMP, GEP, qualification/validation methodologies (IQ/OQ/PQ), and environmental...
in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software. General...
PQ meters. Programming of SEL, GE, PML, Schneider, etc. IEDs for integration. Programming of HMIs. Programming...
for single-use products. Formulate, carry out, and understand validation protocols (IQ, OQ, PQ). Review validation data, craft...
activities and processes. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...