packaging systems for terminally sterilized medical devices. Lead IQ/OQ/PQ and packaging process validation activities..., Alloyd IQ/OQ/PQ and process validation ISO 11607-1 & ISO 11607-2 FDA 21 CFR Part 820 / GMP ASTM & ISTA packaging...
in assembly equipment development, process validation (IQ/OQ/PQ), DFM/DFA, MSA, Gage R&R, FMEA, and process characterization..., PQ road map requirements. Fully understand the equipment development procedure WE0179 and associated deliverables...
documentation for equipment DQ, IQ, OQ, PQ validations. Conduct effective design reviews of new equipment at all stages...
of manufacturing process for minimizing waste and maximizing production. Ensure all process development, validation (IQ, OQ, PQ...: Manufacturing Process Development | Process Validation (IQ/OQ/PQ) | PFMEA | CAPA | NCR | QMS | Risk Assessment | Manufacturing...
, and calibration procedures. Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations. Conduct effective...
, including IQ, OQ, and PQ protocols. Support packaging operations and high-volume packaging equipment. Develop and review... barrier systems, and terminally sterilized medical devices. Experience with ISO 11607, FDA 21 CFR Part 820, GMP, IQ/OQ/PQ...
Specifications Risk Assessments Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ...
and execute DOE, TMV, PCR, IQ/OQ/PQ studies. Apply statistical analysis and advanced problem-solving to improve processes..., TMV, IQ/OQ/PQ, Process Validation, and Statistics. Strong analytical, troubleshooting, and project leadership skills...
, and continuous improvement methodologies. Experience with equipment validation, IQ/OQ/PQ protocols, and process qualification...
with technical and operations teams on equipment validation (IQ/OQ/PQ). Analyze production data to identify trends, root causes...