Location : Remote, once COVID gets better need to be in Princeton, NJ

Role: Computer System Validation lead QA

Duration : Long term

Rate : $55.00 Per hour

The requirement is for a Life Science Domain Expert with Experience in Computer System Validation (CSV) and Knowledge of US and EU Regulations. The resource is required to work closely with Customer to understand the Project requirement and deliver the project in coordination with Offshore team.

• 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 uer 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.