Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author...+years of validation experience in a GMP-regulated environment. Strong knowledge of: IQ/OQ/PQ Process Validation...
activities, including: Supplier pFMEA IQ/OQ/PQ and process validations First Article Inspections and inspection reports Gage...
according to medical device regulations. Validation experience including FAT, SAT, IQ-OQ-PQ, process characterization...
deployments. Oversee: Equipment and process readiness Validation planning and execution (IQ/OQ/PQ) Documentation completion...
/PQ) to meet applicable FDA and regulatory requirements. Qualifications Required Knowledge, Skills & Abilities... equipment Prior experience with process/equipment validation: writing documentation and execution - IQ, OQ, PQ Strong...
writing and executing validation protocols and reports, including IQ/OQ/PQ documentation Proficiency with validation...
per PACS-PQ-0029 and must have a minimum of a 20/25 vision (with correction) Required to lift a minimum of 35 pounds. Lifting...
per PACS-PQ-0029 and must have a minimum of a 20/25 vision (with correction) Required to lift a minimum of 35 pounds. Lifting...
/OQ/PQ protocols and reports. Authors, reviews, and approves validation and change control documents such as master plans...
in defining user requirements for new systems and the execution of equipment/system IQ, OQ, PQ’s. Support content creation...