and systems IQ, OQ, and PQ of fixtures, tooling, and equipment Identify, investigate and resolve manufacturing difficulties...
management from the URS issue to PQ by applying current project managements practices including GMP conform documentation...
protocols for equipment and process validations, including IQ, OQ, and PQ. Assist with the administration of the asset...
, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process... review). Knowledge of plastic injection molding, IQ/OQ/PQ, statistical analysis, PPAP, APQP, supplier quality, CQE, Six...
of equipment qualification protocols (IQ, OQ, PQ). Familiarity with regulatory requirements (e.g., ISO, OSHA) Proficiency... (PQ) protocols for new and existing equipment. Ensure equipment meets regulatory standards (e.g., FDA, ISO, GMP...
dates, and achieving milestones. Responsible for all aspects of process validation, including IQ, OQ, and PQ...
technical adequacy, statistical validity, and regulatory compliance. Review IQ, OQ, and PQ protocols for completeness...
Understanding validation documents, URS, IQ, OQ, PQ Verifying system drawings including ability to review and as-built P&IDs...
able to qualify laboratory equipment to include authoring and execution of IQ/OQ/PQ protocols and reports. Conduct testing...
maintenance and calibration schedules;manage qualification status (IQ/OQ/PQ), lifecycle tracking, service history, and audit...