in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software...
/Manufacturing;define readiness and execute in QC. Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training...
(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...
for single-use products. Formulate, carry out, and understand validation protocols (IQ, OQ, PQ). Review validation data, craft...
scripts, traceability matrices, and validation reports Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA... validation activities including IQ/OQ/PQ, requirements development, test execution, and traceability Familiarity...
, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
design Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability...
requirements, including ownership of process validation (IQ/OQ/PQ), documentation, and audit support Cross-functional... Skills: Strong technical background in process validation (IQ/OQ/PQ), statistical process control (SPC), and data driven...
activities and processes. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...
/OQ/DQ/PQ). Provide production line support for day-to-day engineering issues on core instrument lines i.e. resolve...