Maintenance, Jidoka, PQ/PR, Takt Cycle, Standard Work, Value Stream Maps, Kaizen, 4D/8D/A3 Problem Solving, and Poka Yoke...
manufacturing work environment. Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ...
results. Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases. Serve as the QA lead...
equipment. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning... equipment qualification. Hands-on experience with IQ/OQ/PQ protocol authoring and execution. Knowledge of FDA, cGMP, GAMP 5...
Assessments, Traceability Matrices, and Validation Summary Reports. Execute and oversee IQ, OQ, and PQ activities. Ensure...
improvement projects, etc;and the documentation required Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing...
for URS, FAT, IQ, OQ, PQ and successful vertical start up As a project manager provides direction to allied support groups...
support IQ/OQ/PQ Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc) - use of Minitab Software for analysis...
(IQ/OQ/PQ) in collaboration with Quality and Validation teams. Ensure all automation, equipment, and process...
), and Performance Qualification (PQ) for new and existing manufacturing equipment. Perform change assessments and lead requalification..., or other regulated industries. Experience performing equipment qualification activities (IQ/OQ/PQ). Experience supporting sterile...