. Hands-on experience with CAPA, Company, validations (IQ/OQ/PQ), and audits. Proficient in quality tools such as FMEA, 8D...
systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ... such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports. Demonstrated...
Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Create change controls, periodic...
, and maintain validation activities (IQ/OQ/PQ) across manufacturing equipment, processes, and inspection methods. Establish... (IQ/OQ/PQ) Inspection method development (Gauge R&R, sampling plans, MSA) Quality data analysis and trending...
, and analytical methods Develop and execute validation protocols (IQ/OQ/PQ) and maintain validation master plans for cell & gene...
of GD&T and ability to read and interpret drawings. Good understanding of process validations (IQ, OQ, PQ) Good...
within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does...
within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does...
-to-date, and compliant with regulatory and company standards. · Support validation activities including IQ/OQ/PQ for equipment...
capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues...