• 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 customers SOP Reviewing and verify execution of CR Monitoring CR through closure • Monitoring deviations and CAPAs for extension amendment approval and closure • Conduct postimplementation periodic review of systems • Dry run and execute test protocols Review executed test scripts • 3-5 years of relevant experience • Hand on experience of supporting Computer System Validation • Experience with industrystandard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5 • Knowledge of GxP best practices international standards to quality management and methodology • Proven experience collaborating with others including employees and contractors • Effective communication skills written and oral • Effective and independent problemsolving skills • Great team player