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...
, thermography, oil analysis). Experience troubleshooting equipment commissioning/qualification (IQ/OQ/PQ) and completing compliant...
/OQ/PQ). Provide assistance and/or perform inspection, and electrical safety testing. Ability to perform basic statistical...
readiness. Oversee prototype builds, tooling design/build, and validation activities (IQ/OQ/PQ). Align manufacturing readiness...
/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...
(customer). Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning...
Quality AuditorKnowledge of validation processes (IQ, OQ, PQ, PPAP). Knowledge of quality core tools such as FMEA, 8D...
Administration or another related field Certified Quality Auditor Knowledge of validation processes (IQ, OQ, PQ, PPAP) Knowledge...
), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for cleanrooms, HVAC systems, compounding equipment.../211 regulations. Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change...
: Review GMP validation documentation for Risk Assessment, System Classification, URS, IOQ, PQ protocols and reports...