Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols... compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations. Partner with R&D, Quality Assurance, and external vendors...
, process, software, and product validation activities (IQ/OQ/PQ) as required. Ensure document control processes are followed... technical discipline. 2-5+years of experience in Quality Systems, Quality Engineering, or Quality Assurance...
activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification... while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Qualification (IQ...
activities. Design, validate, and document manufacturing processes, including Installation Qualification (IQ), Operational... Manufacturing, Quality Assurance, R&D, Maintenance, Supply Chain, and Regulatory Affairs. Support equipment selection, installation...
and finished vehicle operations, and robust supplier quality assurance. The position involves driving compliance, managing new..., and the QR2 System utilization. Support VRT's with supplier quality concerns and IQ support for weekly meeting Push known...
Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author..., Quality Assurance, Manufacturing, Automation, and Regulatory teams. Mentor junior validation engineers and specialists...
and finished vehicle operations, and robust supplier quality assurance. The position involves driving compliance, managing new.... Champion the Incoming Quality activity, and the QR2 System utilization. Support VRT's with supplier quality concerns and IQ...
and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Quality Assurance... in a biological Science. Experience Work requires six years of experience quality assurance or quality control related to clinical...