Job Summary

We are looking for a seasoned IT CSV Lead with solid 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

' 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 Requirements

- Immediate joiner preferred

📌 Senior IT CSV Lead (10–12 Years Experience, Immediate Joiner) (Chennai)
🏢 Archimedis Digital
📍 Chennai