for single-use products. Formulate, carry out, and understand validation protocols (IQ, OQ, PQ). Review validation data, craft...
, and delivery. Execute validation and qualification (IQ/OQ/PQ) protocols for new products, equipment, tooling, and processes...
(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...
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...
, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
activities and processes. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...
, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
regulations within the E.U. and U.S. FDA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
the execution of FMEA, FAT, IQ/OQ, PQ and CQV processes to ensure robust project outcomes. Develop technical documentation...: Advanced degree in an engineering discipline Strong knowledge of qualification/validation methodologies (FMEA, FAT, IQ/OQ/PQ...