, 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....
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...
, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs...
manufacturing processes. Perform and analyze IQ, OQ, and PQ qualifications along with other validation activities. Lead PFMEA... medical device industry (pharmaceutical experience not applicable). Hands-on experience executing IQ, OQ, PQ, and conducting...