Lab System Validation

Job-ID32463871Reference26-01008 Remote 50% Remote

Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred. To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. Exposure to Regulatory Audits and Remediation activities Ensure the CSV artefacts are in line and meets regulatory requirements Preferred Experience in Agile Development Knowledge on working in Jira / Service NowAdaptation to AI is preferred. Testing (in addition to above) Experience in testing and knowledge in any one of the QC/R&D Lab systems is must. Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must. Knowledge on working in Jira, Client ALM or any automation testing tools.