for new projects. Develop manufacturing process for new projects. Perform IQ, OQ, PQ protocol writing and validation...
of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the..., and executes test cases. Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change...
and facilitates execution of process validation activities and documentation e.g. IQ/OQ/PQ Leads bench testing method creation... e.g., IQ/OQ/PQ, Gage R&R Able to characterize and determine process capability using statistical analysis to determine...
understanding of capital equipment implementation and process knowledge Understanding validation documents, URS, IQ, OQ, PQ...
equipment within our facility. The ideal candidate will have a strong background in IQ/OQ/PQ processes, fill-finish... Qualification (OQ), and Performance Qualification (PQ) for large equipment. Ensure that all processes align with regulatory...
Bioanalytical project data for submission to e.g., FDA, EMA; Prepare and review Protocols, SOPs, Forms, IQ/OQ/PQ documents...
fulfillment of all requirements including IQ/OQ/PQ validation and verification activities. Ability to create and execute quality...
within the facility. The specialists will be responsible for all aspects of commissioning, qualification (IQ/OQ/PQ... Qualification (OQ), and Performance Qualification (PQ) processes for large equipment, ensuring compliance with regulatory standards...
) and internal SOP's Support onboarding of new instrumentation including performing/reviewing IQ/OQ/PQ data or qualifications...
for IQ/OQ/PQ validations of injection molding tools, processes, equipment, and metrology, ensuring compliance and best-in...