Microbiologist
) and internal SOP's Support onboarding of new instrumentation including performing/reviewing IQ/OQ/PQ data or qualifications...
) and internal SOP's Support onboarding of new instrumentation including performing/reviewing IQ/OQ/PQ data or qualifications...
’s, PQ’s, and validations Read schematics, assembly drawings, data sheets, and work instructions to perform testing...
, OQ, PQ) for aseptic fill equipment and utilities. Ensure aseptic filling equipment meets regulatory standards and GMP...
Responsibilities: Develop and execute validation strategies, protocols (IQ, OQ, PQ), and reports for computerized systems..., ISO 13485, GxP, and GMP compliance. Proficiency in developing and executing validation protocols (IQ, OQ, PQ...
installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) Monitors and analyzes...
, OQ, PQ) for aseptic fill equipment and utilities. Ensure aseptic filling equipment meets regulatory standards and GMP...
Integration Testing, FAT, SAT, IQ, OQ, PQ, Risk Assessment, TM, Deviations, Code Reviews, Release Notifications and Master Plans...
procedures and traceable to NIST. Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities...
of process validations (IQ, OQ, PQ). Knowledge of basic statistics concepts. Proficient technical writing skills. Proficient...
CQV Activities: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ...