Computer system Validation tester

Computer System Validation Specialist• 8+ years of experience in CSV Implementation • Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan • Experience in CSV for Lab systems especially LabVantage version 8, Serialization, trackwise systems • CSV/21CFRPart11/GxP/ • Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc. • Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan • Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation • Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV • Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures. • Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel • Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems • Responsible for review & verification of Corrective Action Plan for audits • Perform periodic review/monitoring of computer systems implemented • Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process Key Skills: Computer System Validation for Lab systems