Senior Specialist Pharmaceutical Quality Systems
maintenance and calibration schedules;manage qualification status (IQ/OQ/PQ), lifecycle tracking, service history, and audit...
maintenance and calibration schedules;manage qualification status (IQ/OQ/PQ), lifecycle tracking, service history, and audit...
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...
’s or Bachelor’s degree in Engineering, Science, or a related technical field Key Responsibilities: Execute IQ, OQ, PQ protocols...
IQ/OQ/PQ. Configure MES platforms, troubleshoot batch issues, and integrate MES with ERP, LIMS, QMS, and historian...
able to qualify laboratory equipment to include authoring and execution of IQ/OQ/PQ protocols and reports. Conduct testing...
regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing Experience applying...
IQ/OQ/PQ. Configure MES platforms, troubleshoot batch issues, and integrate MES with ERP, LIMS, QMS, and historian...
industry, specifically VMP/VMR, IQ/OQ/PQ, DOE, and TMV. Proven experience tracking and managing technical risks and providing...
technical adequacy, statistical validity, and regulatory compliance. Review IQ, OQ, and PQ protocols for completeness...
elements (PPAP/FAI, capability studies, MSA/Gage R&R, process validation IQ/OQ/PQ where applicable). Collaborate with Design...