execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies. Define.... Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...
qualification (IQ, OQ, PQ). Develop, review, and execute validation protocols and reports in compliance with GMP standards...
and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification. Make independent decisions...
processes (IQ/OQ/PQ) Experience in building an organization Support of a 24/7 production operation Experience in an FDA...
including EO parametric requirements, DEO, SLR and cycle calculations. Lead and execute validation activities (IQ, OQ, PQ...
customers. You’ll lead continuous improvement efforts, develop and validate robust manufacturing processes (IQ, OQ, PQ, gauge... or updated assembly procedures to ensure smooth production readiness. Lead process validation activities, including IQ, OQ, PQ, gauge R&R...
strategies, and on-going controlled environment data. Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ’s and Change Controls...
, installation, and IQ/OQ/PQ of new instruments and equipment. Work with other team members to manage the OpenLab chromatography...
, and IQ/OQ/PQ. Monitor yields, troubleshoot production issues, and drive corrective actions. Conduct performance reviews...-on experience with validation (IQ/OQ/PQ) and process documentation. Knowledge of FDA 21 CFR 820, ISO 13485, and international...
Manufacturing and QA with Performance Qualification (PQ) activities if applicable. Related Activities: Participate or lead...