-on experience in: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) CSV... & Responsibilities Develop, review, and execute validation protocols including IQ, OQ, PQ, CSV, and system validation documentation...
, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), Operating and Maintenance Instruction Conduct risk assessments and impact analyses...
. Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes. Lead the design...
Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
results. Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases. Serve as the QA lead...
, including authoring and executing characterization, IQ/OQ/PQ, and equipment technical documentation in compliance...
and preventive actions to completion Own process and software validation activities, including PFMEA, IQ/OQ/PQ, PPAP, and FAIR...
in: o Protocol writing (IQ, OQ, PQ, CSV, system validation) o Validation execution and reporting Deep understanding of: o FDA...
, and process improvements. Includes participation in URS development, FAT, IQ/OQ/PQ, and successful vertical start-up. Acts...
functionality, and IQ/OQ/PQ validation. They will help drive IT setup, repeatable deployment plans, QA validation, maintenance...