. Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols...
. Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols...
maintenance is on time and effective Perform IQ, OP, PQ for new laboratory equipment Perform laboratory bench work and testing...
. Plan and execute IQ/OQ/PQ qualifications. Support process and cleaning validations. Create and maintain validation...
, validation master plan, develops validation protocols for PQ, supports IQ/OQ in conjunction with the engineering team. Lead...
justification for capital projects New equipment implementation/validation (IQ, OQ, PQ) Confer with management, engineering...
implementation/validation (IQ, OQ, PQ) Confer with management, engineering, and other staff regarding manufacturing capabilities...
/requalification (IQ/OQ/PQ) and maintain environmental monitoring programs (particulates, temperature, humidity, differential pressure... validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, GMP, and internal quality standards. Ensure all processes...
Validation & Product/Equipment Transfer Lead and execute process and equipment validations (IQ/OQ/PQ) for new, transferred... activities (IQ/OQ/PQ) and establish environmental monitoring programs (particulates, temperature, humidity, differential pressure...
lifecycle (IQ, OQ, PQ, protocols, test scripts, infrastructure qualification, backup/restoration, and audit trail testing...