) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ... and performance qualification (IQ/OQ/PQ) protocols Ability to use AutoCAD, Revit, Visio Engineering, communication...
Validation & Quality Systems Support IQ/OQ/PQ validation activities Ensure compliance with ISO 13485, FDA, and GMP requirements...
/execution, IQ/OQ/PQ, traceability, deviations, and maintaining validated systems. Deep expertise with 21 CFR Part 11, EU Annex... Validation (CSV), GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, Data Integrity, Validation Plans, IQ/OQ/PQ, Risk Assessments...
, and maintain injection molding processes for high-quality production Lead process validation activities (IQ/OQ/PQ) and maintain..., optimization, and troubleshooting injection molding processes. Experience with process validation (IQ/OQ/PQ) Familiarity...
FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier Partner with internal design teams... IQ/OQ/PQ protocols/reports required. Experience designing and executing Gauge R&R studies preferred. Demonstrated...
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...
Risk Assessments IQ/OQ/PQ Activities Test Script Execution Defect Management Traceability Requirements Verification...
and associated system(s) (Loans PQ – loans decisioning system) Proven ability to garner business Genuine interest in helping...
manufacturing processes Lead IQ, OQ, and PQ validation activities Manage medium to large capital equipment projects Troubleshoot... guidance Required Skills IQ, OQ, PQ validation experience Capital project management experience Statistical analysis...