Job Summary
We are looking for a seasoned IT CSV Lead with robust hands-on experience in Computer System Validation (CSV) and hands on in testing activities within regulated environments. The candidate should be self-driven, capable of reviewing and overseeing validation and testing deliverables, managing teams, and owning client expectations end-to-end.

Key Responsibilities
CSV & Validation Leadership
Lead end-to-end CSV activities across the system lifecycle
Author, Review and approve validation and testing deliverables, including:
Validation Plans / Strategies
URS, FS, DS
Risk Assessments
IQ/OQ/PQ protocols and reports
Traceability Matrices
Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 requirements

Testing & Hands-on Execution
Be hands-on in testing activities, including:
Functional testing
ETL / Data validation testing
Report testing (if applicable)
Review test cases, test execution evidence, defect reports, and test summary reports
Support and guide teams on risk-based and pragmatic validation approaches
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Team & Client Management




Lead and mentor onshore/offshore testing and validation teams
Perform task allocation, review work products, and ensure quality delivery
Manage client expectations, handle escalations, and act as the primary point of contact
Drive delivery timelines and ensure adherence to agreed milestones

Mandatory Skills & Experience
10–12 years of experience in IT CSV / GxP Validation
Strong experience in reviewing validation and testing activities
Hands-on experience in manual testing and validation execution
Excellent communication and stakeholder management skills
Proven experience in team handling and delivery ownership
Ability to work independently with minimal supervision

Good-to-Have (Added Advantage)
ETL / Data Warehouse Testing experience
Automation testing exposure (any tools/frameworks)
Experience in report validation (Power BI / Tableau / Cognos, etc.)
Knowledge of risk-based validation / CSA principles

Other Requiremen

📌 Senior IT CSV Lead (Chennai)
🏢 Archimedis Digital
📍 Chennai