including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports. Ensure compliance with FDA, GAMP 5, 21 CFR Part 11...
, 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...
: 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....
safety perspective. Support contract manufacturing in performing equipment IQ, OQ, and PQ. Maintain and update packaging... to provide technical solutions. Proficiency in SolidWorks to create packaging concepts and drawings. Experienced with IQ/OQ/PQ...