Client is looking for a resource who can review and approve Computer System Validation protocols for Automated and Computerized Systems within the manufacturing facility. The protocols will be written and executed by others and this role strictly entails review and approving those protocols/deliverables/reports for quality. Examples of the system deliverables include, Requirement Specifications, Configuration specifications, test plans, requirements traceability matrices, Automation change controls, data integrity assessments, etc. Understanding of FDA regulations/guidance and various GAMP guidance documents, along with V model and other approaches to SDLC validation. Main duty as mentioned is the QUALITY OVERSIGHT piece and signing off for quality. Specific Manufacturing systems here are of interest, DeltaV, PLC, BAS, etc.
Quality Review, Approval/Approve, DeltaV, PLC, SDLC
Experience outweighs degree
Remote in NC: CSV Review of Automated Systems (232781)