Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience...
, launches, and production ·Validate (IQ/OQ/PQ) production processes to meet customer requirements for technical specifications...
tablets/capsules to complex medical devices. They focus on equipment development, qualification (IQ/OQ/PQ), troubleshooting..., pneumatic, and control subsystems. Develop and execute equipment qualification protocols (IQ, OQ, PQ) to support regulated...
Maturation of all parts prior to mass production. Provide status updates with the PQ management team. Provide analysis...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
equipment validations such as IQ/OQ/PQ. Create detailed specifications and execute Factory and Site Acceptance Testing (FAT...
, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms... experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
) to validate and improve products and establish robust manufacturing processes;ensure completion of process validations (IQ/OQ/PQ...