of PFMEAs and control plans. Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV). Lead manufacturing...
sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the... documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA...
by responding to work requests and offering assistance promptly Support commissioning, validating (IQ/OQ/PQ) and testing of new...
, and communication updates. Execute or support process validation activities (URS, FDS, FAT, SAT, OQ, PQ). Drive development...
Technology;or Physics Preferred Qualification “PQ” – Bachelor’s Degree in Mechanical, Manufacturing, or Civil Engineering Two...
products meet regulatory and quality requirements. Drive process qualification and validation activities (IQ/OQ/PQ) to support...
acceptance testing (FAT), and qualification — and assist in the development and execution of IQ/OQ/PQ as well as process...
, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports Applies knowledge and expertise to solve complex...
and provide feedback on SFMD supplier IQ/OQ/PQ, test method validations (ATMV/VTMV), and PFMEA content Providing onsite training...
plans, and reports in alignment with FDA, ISO, and equipment validation best practices. Perform IQ/OQ/PQ activities for lab...