Job Description :
Job title: CSV/ Validation Tester Location : Princeton, NJ (Remote Start ) Duraiton: Long term Minimum 6-8 years of hands on experience in Computer System Validation as a Validation Analyst/Lead Independently lead the validation activities Author, review and approve Validation Plan (VP) and Validation Summary Report (VSR) for the project. Review user and functional requirements (URS and FRS) for ambiguity, completeness and correctness. Define test strategy as per GAMP5 risk based testing (functional risk assessment) Review and approve IQ, OQ and PQ for test coverage and test mapping (RTM Ability to manage and assign work of 1-2 Validation Analysts. Ability to understand and enforce compliance to client's CSV SOPs. Ability to schedule and lead meetings, moderate decisions and negotiations. Ability to course correct, develop next steps and define path forward in strategic/tactical situations within project life-cycle.