QMS processes managed within PLM or integrated systems. Support Computer System Validation (CSV) activities (IQ/OQ/PQ...
Knowledge of validation (IQ/OQ/PQ) and risk management (FMEA) Work Environment Combination of office and manufacturing floor...
, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations...), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance...
planning, testing (IQ/OQ/PQ), detailed documentation, change control around computer systems for quality, manufacturing...
or Six Sigma certification preferred Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting...
/OQ/PQ), test scripts, and reports. Review and approve validation lifecycle documentation including URS, risk assessments...
(CQV) activities for OSD manufacturing and packaging systems Develop and execute risk-based IQ/OQ/PQ protocols aligned... and/or packaging environment Proven experience in authoring and executing IQ/OQ/PQ protocols and validation reports Experience...
for plant trials, packaging component testing, and supports protocol development for IQ, OQ and PQ of capital equipment...
, IQ/OQ/PQ, TSR, SOPs) Experience in UAT, Traceability Matrix & QA methodologies Ability to lead teams & manage multiple...
System, Electrical, CDA, Nitrogen. Assist in the execution of equipment IQ/OQ/PQ in GMP manufacturing Support and maintain...