Description
My client is seeking a CSV Validation Lead for 3000L Fermenter SCADA Project for a 6-12 month contract based in South -WestDeliverables - The post will support a new project to implement a new Integrated SCADA control system for the 3000L Fermenter project within a GMP environment.
Activities to include and not limited to:-
- Generate System and Component level Impact assessments following the recognised ISPE baseline guides.
- Generate Computerised Impact assessment following recognised GAMP 5 Practices - Review vendor audit information and implement/expedite the required Quality mitigations.
- Review of URS including, participating in URS and subsequent design review workshops - Review of Functional Specifications - Generate Qualification Plan
- Generate Requirements Traceability Matrix - Review of the Design of the System, conducting the necessary expedition activities and reporting on findings to the Project Manager.
- Coordinating with the SCADA Vendor and individual equipment package vendors in relation to the delivery of their integrated control systems. - Expedite Design Qualification activities
- Review of IT platform requirements, including participating in IT platform requirements workshops.
- Arrange additional qualification of IT platform if required - Generate / approve Configuration Specification
- Review and approval of FAT Protocol /Report - Participating and delivery of FAT - Review and approval of SAT Protocol /Report
- Participating and delivery of SAT - Review and approval of IQ/OQ Protocol. - Participating and delivery of IQ/OQ - Generation of IOQ Report - Generate Validation Interim Summary Report
- Participating and delivery of PQ Protocol - Review of Completed PQ Protocol - Generation of PQ Report - Generation of Final Validation Summary Report - Liaise with Key Stake Holders/ user departments, QA, Validation, IT, Vendor (Zenith Technologies), System Owner and senior management team - Report and liaise with project team to resolve issues - Implement the required asset care plans including Administration SOP's meeting the requirements of Annexe 11 and 21CFR Pt 11 _________________________________________________________________________ Key Skills - Extensive knowledge of GAMP4/5 life cycle - 21 CFR Part 11 - Annex 11 - Proven track record of CSV experience of complex IT projects - Ideally, familiar with IMS systems, specifically Wonderware Intouch, and Siemens - Familiar with risk based approach to validation ______________________________________________________________________ If this opportunity is of interest please do send me an updated CV to or call me on . I look forward to hearing from you. Kind regards
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