, functional and configuration specifications, risk assessments, test protocols, IQ/OQ/PQ documentation where applicable..., deviations, summary reports, and IQ/OQ/PQ documentation where applicable. Experience validating configurable software, SaaS...
, OQ, PQ validation process. Document in detail, molding process, mold set up, work cell layout, and troubleshooting.../PQ) Interpretation of DOE and basic statistical analysis Handling of auxiliary equipment (dryers, chillers, hot runners...
, OQ, PQ) Develops and implements methods and procedures for disposition of discrepant material and devises methods...
at a local or franchise level.Product Grading / Process. Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation...
, validating production equipment (IQ/OQ/PQ), and optimizing quality inspection parameters (Smart Inspection) . Strong leadership...
as required to support compliant sample testing Develop and execute system testing and validation deliverables (IQ/OQ/PQ, test scripts...
corrective actions. Apply SPC, DOE, Six Sigma, IQ/OQ/PQ, Gage R&R, normality testing, and Ppk/Cpk capability analysis, using.... Experience with Silicone Molding. Experience with IQ/OQ/PQ process validation in an FDA 21 CFR 820 / ISO -regulated environment...
engineering, a BS in a technical field, and strong project management with knowledge of FMEA, SPC, GR&R, CAPA/RCA, and IQ/OQ/PQ...
throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely...
Qualification) and PQ (Performance Qualification). Strong project management skills, including development and management...