Job Description :
Title : Validation Lead
Location: Princeton, NJ
Position Type: Contract
Job Description:
· 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.