(OQ), and Performance Qualification (PQ) processes. Ensure sterilization and packaging meet regulatory standards... with IQ, OQ, and PQ validation processes. 3-5 years of experience in the medical device industry, preferred. Additional...
, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff...;specification, comparability, and stability programs;site and method transfers;product quality impact statements for NCs;and PQ...
Biorefining standard operating procedure. Perform NIR IT (PQ) testing on a weekly basis and report any test failures to the... of cGMP, PI, QC and PQ reporting preferred. Excellent organizational, time management and communications skills as well...
, and in compliance with the quality management system. This includes IQ/OQ and PQ process. Resolves problems such as production process...
process validation activities, including IQ, OQ, and PQ protocols and reports. Act as a liaison with regulatory bodies...
: Review GMP validation documentation for Risk Assessment, System Classification, URS, IOQ, PQ protocols and reports...
, and direct-labor manufacturing personnel. Knowledge of DFMEA, PFMEA, Control Plans, IQ/OQ/PQ Ability to define problems...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
, and PQ processes Provide statistical support to analyze manufacturing processes and to recommend appropriate process...
evaluations, and equipment readiness assessments for new and existing lines. Execute IQ/OQ/PQ protocols, ensuring alignment.... Proficiency with Cognex/Keyence vision systems. Demonstrated experience executing IQ/OQ/PQ validation in regulated environments....