Control Systems / CSV Expert
Control Systems / CS
United Kingdom,
Permanent
22 March 2023
- Works with clients IT and cross functional departments in development and implementation of an efficient Software/Computer Validation Program for automated equipment, processes, and information management systems for the manufacturing Operations.
- Identifies computerized systems validation needs through in-house / external assessments.
- Responsible for the development of Software/Computers validations Protocols and final report as well as to coordinate and perform activities as per approved protocol.
- Works with systems owners to ensure validation is conducted prior to deployment of GxP systems and systems are maintained in a validated state.
- Work closely with IT to meet relevant regulations, such as FDA 21 CFR Part 11 and TGA Annex 11.
- Deviations from or corrective actions for any part of the Computer and Lab Systems Quality System based on written justification and cross functional review of impacted parties.
- Participate as assigned IT Representative or lead project teams to implement and validate computerized or automated Lab Instrumentation / process equipment and associated computer hardware and software.
- Experience with ISPE GAMP Computer System Development Life cycle methodology is a must.
- Knowledge of Client Server environment, UNIX, NT, Windows, Data communications equipment (Routers, Switches, LAN/WAN, PLC, SCADA).
