. Assume full ownership of PQ process validation planning, execution, and reporting. Assume full ownership of equipment, test...
Commissioning and Qualification (C&Q) Develop, author, and execute C&Q protocols (IQ/OQ/PQ) for the new filling line, focusing...
Qualification (OQ), and Performance Qualification (PQ). Knowledge of CAPA, change control, and product lifecycle management...
documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Ensure...
, and IQ/OQ/PQ. Own component-related change management, impact assessments, and workflow governance using relevant systems...
(IQ/OQ/PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team...
Job Description Must-Have Skills Strong expertise in V&V for medical devices · Hands-on experience in: Protocol writing (IQ, OQ, PQ, CSV, system... within a defined timeline Key Responsibilities: Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system...
, process validations, and product validations, including IQ/OQ/PQ activities for QC equipment. Create, review, and approve.... Hands-on experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ...
washers, cycle development, and PQ/PV execution. Responsibilities Perform validation activities for aseptic liquid fill... manufacturing equipment. Execute cycle development for autoclaves and parts washers. Perform PQ/PV activities on assigned...
Support SIT, UAT, PQ, and production deployments in coordination with business and QA teams Ensure adherence to client...