Archimedis Digital
Website:
archimedis.io
Job details:
Job Summary
We are looking for a seasoned IT CSV Lead with strong 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
- 5–10 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
Click on Apply to know more.
