is strongly preferred. Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ...
with other staff. Develop manufacturing specifications for products and validation activities with Quality/IQ/OQ/PQ. What You’ll...
expectations. Author and/or approve URS, FAT/SAT protocols, commissioning documentation, and IQ/OQ/PQ protocols and reports... systems in a GMP-regulated manufacturing environment. Experience with equipment validation (IQ/OQ/PQ) and lifecycle...
to Have: Experience in validation and performance analysis (MSA, IQ/OQ/PQ, TMV) Ensuring regulatory compliance and reliability...
to: FAT, SAT, IQ, OQ, PQ, and PV Review and approval of validation documents including but not limited to: GxP Assessment..., Risk Assessment, Part 11/Annex 11 Assessment, Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS...
), PQ (Performance Qualifications), and FQ (Fixture Qualifications) protocols to qualify products. Conduct test method...
validation teams to ensure successful validation (IQ/OQ/PQ). Design, engineer, and modify existing and new moderately complex...
and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically...
and/or approve URS, FAT/SAT documentation, commissioning plans, and IQ/OQ/PQ protocols and reports for packaging equipment. Lead... environment. Experience with automated packaging equipment and line integration. Experience with process validation (IQ/OQ/PQ...
Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...