Validation & Quality Systems Support IQ/OQ/PQ validation activities Ensure compliance with ISO 13485, FDA, and GMP requirements...
and facility transfers Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ) Update...
and facility transfers Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ) Update...
development Troubleshoot complex molding, tooling, and production issues Validation & Quality Systems Support IQ/OQ/PQ...
and facility transfers Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ) Update...
and facility transfers Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ) Update...
documentation, including Validation Plans, URS, Risk Assessments, Design Qualification, IQ/OQ/PQ protocols, traceability matrices..., utilities, facilities, laboratory instrumentation, and computerized systems. Hands-on experience with IQ, OQ, PQ, FAT, SAT, risk...
using data analysis and Six Sigma methodologies. Coordinate installation, validation (IQ/OQ/PQ), and optimisation of new...
on process re-qualification (IQ/OQ/PQ) Update quality documentation, inspection plans, and risk assessments during transitions...
including IQ, OQ, PQ, UAT, and system qualification. Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data...