&D into full-scale production. Own and execute process validation activities, including IQ/OQ/PQ and PFMEA. Develop and maintain...
(SO) for syringe filling equipment from design through to PQ and commercial operation. SO during equipment implementation, FAT/SAT..., commissioning, qualification (IQ/OQ/PQ), and validation activities. Drive manufacturing readiness, start-up, and handover...
, DQ/IQ/OQ/PQ documentation, periodic reviews, alarm/limit management, and criticality assessments. Ensure utilities remain... & Validation: Proficiency with URS, DQ/IQ/OQ/PQ, calibration/metrology, alarm philosophy, and maintaining validated state...
environment is required Experience with executing IQ/OQ/PQ protocols and administering software databases and working knowledge...
/PQ or equivalent) to support system changes and new MES functionality. Support computer system validation (CSV... and CSV expectations. Develop, execute, and review test scripts (IQ/OQ/PQ or equivalent) to support system changes and new...
environment is required Experience with executing IQ/OQ/PQ protocols and administering software databases and working knowledge...
. Perform basic troubleshooting and escalate equipment issues appropriately. Participate in equipment qualification (IQ/OQ/PQ...
) and Performance Qualification (PQ);review and approve validation work and ensure regulatory compliance. Own and drive closure.../process engineering Demonstrated experience leading validation activities including IQ, OQ and PQ for equipment, processes...
Qualification Protocols (IQ/OQ/PQ) Requirements Traceability Matrices (RTMs) Validation Summary Reports Design, generate...
activities in collaboration with the Quality team Assist with the development and execution of IQ, OQ, and PQ protocols...