Computer System Validation - CSV

CSV Location: Woburn, MA (Initially Remote)Duration: 6-12 Months Work on CSV requirements for the laboratory applications and Benchtop equipment which includes software applications like Labvantage, CMMS, EDR, JMP and Kinaxis.Job Description:Create a validation plan using a risk-based approach.Create a validation report that verifies compliance to the plan.Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable.Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached.Write, review, evaluate the configuration management plans and procedures associated with the development process.Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix.Raising a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per customer’s SOP; Reviewing and verify execution of CR; Monitoring CR through closure Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per customer’s SOP.Raising an IT CAPA, initiation, action processing, root cause analysis.Monitoring deviations and CAPAs for extension, amendment, approval, and closure.Conduct post-implementation; periodic review of systems.Dry run and execute test protocols. Review executed test scripts.Qualification of Manufacturing EquipmentBackup and Restore testing support CSV LeadLocation: Sunnyvale, CADuration: 6-12 Months CSV Lead with 10+ years of experience in Clinical applications like Medidata Rave EDC, Clinical Trial Management Systems, Veeva applicationsJob Description:Provide the Computer System Validation (CSV) Services for Initial GxP Validation of the Medidata Data Capture (EDC) System. Perform System Level GxP Risk Assessment, Functional Risk Assessment, Validation Plan/Strategy and Report, Compliance Requirements, Authoring of Operational Qualification (OQ) and Performance Qualification (PQ)Plan and Setup Data for Test ExecutionResponsible for Execution of test protocols (OQ, PQ)Manage IT Change Requests, IT Deviations and IT CAPAsReview any Training MaterialsConduct Periodic ReviewsDefine/Establish validation process for validating upgrades, minor/ major releasesCreate Regression suites that can be leveraged for ongoing validation effortsReview the vendor’s product release notes to evaluate impact on Client ImplementationCSV LeadLocation: San Francisco, CA (Initially Remote)Duration: 6-12 Months Computer System Validation (CSV) Lead with experience in Veeva Vault Platform, Clinical applications, Quality Management Systems and Document Management Systems. The resource should be able to manage the team and drive the project.Job Description:Responsibilities including, but not limited to: Create a validation plan using a risk-based approach.Create a validation report that verifies compliance to the plan.Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable.Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached.Write, review, evaluate the configuration management plans and procedures associated with the development process.Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix.Raising a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per customer’s SOP; Reviewing and verify execution of CR; Monitoring CR through closure Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per customer’s SOP.Raising an IT CAPA, initiation, action processing, root cause analysis.Monitoring deviations and CAPAs for extension, amendment, approval, and closure.Conduct post-implementation; periodic review of systems.Dry run and execute test protocols. Review executed test scripts.