for product changes and process validations (IQ/OQ/PQ), including risk assessments, compliance verification, and coaching teams...
and drive rapid issue resolution. Lead process validation, test method validation, and equipment qualification (IQ/OQ/PQ...
-of Line test equipment through IQ, OQ, PQ approvals (Hardware, Software, and Firmware) Drive project meetings with a focus...
quality, performance, and cost targets. Lead process validation (IQ, OQ, PQ) to ensure compliance with FDA QSR, ISO 13485...
activities (IQ/OQ/PQ where applicable), test summaries, validation summary reports, and release documentation to support system...
(URS), IQ/OQ/PQ, etc. Associates Degree (± 13 years) with Related with 10-15 years relevant experience. Bachelors...
Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Create change controls, periodic...
and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ...
and coating systems and documentation. Support startup activities including commissioning, IQ/OQ/PQ protocols, and integration...
& Qualification Life Cycle Lead IQ/OQ/PQ strategies for equipment, processes, packaging, and software where applicable. Develop...