Validation QA Tester - AI & CSV

We are seeking a Validation QA Tester with strong experience in Computer System Validation (CSV) within GxP-regulated environments, and a growing interest or exposure to AI/ML-enabled applications.

This role sits at the intersection of quality assurance, clinical systems, and emerging AI technologies. You will be responsible for ensuring that modern clinical trial platforms - including those powered by LLMs, RAG systems, and predictive models - are compliant, reliable, and fit for purpose in line with global regulatory standards.

What You'll Be Doing

- Lead and execute end-to-end CSV activitiesfor clinical trial systems with embedded AI components
- Review and contribute to URS, FS, DS, and maintain Requirements Traceability Matrices (RTM)
- Author and execute IQ/OQ/PQ protocolsand both manual and automated test scripts
- Develop Validation Plans, Risk Assessments, and Summary Reportsusing a GAMP 5 risk-based approach
- Manage defects, deviations, CAPAs, and change controlswithin QMS frameworks
- Design and implement validation strategies for AI/ML features(LLMs, RAG tools, predictive models)
- Build and maintain evaluation frameworksto measure accuracy, hallucination rates, and safety
- Perform drift monitoring, adversarial testing, and AI risk validation (e.g., prompt injection, bias, PII leakage)
- Ensure audit trails, HITL controls, and prompt versioningare validated and maintained
- Support regulatory inspections and audits(FDA, EMA, MHRA)

What We're Looking For




- 4-7 years' experience in CSV / Validation QAin a GxP-regulated environment
- Solid background validating clinical systems(e.g., EDC, CTMS, eTMF, IRT/RTSM, ePRO/eCOA)
- Working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6 (R3), GAMP 5, and ALCOA+ principles
- Exposure to AI/ML systems in regulated environments(highly desirable)
- Familiarity with emerging frameworks such as FDA GMLP, PCCP, EU AI Act

Technical Skills
- Experience with test management tools(e.g., Jira/Xray, Azure DevOps)
- Automation tools such as Selenium or Playwright
- Proficiency in Pythonand working knowledge of SQL
- Understanding of CI/CD pipelines, Git, and version control
- Knowledge of ML lifecycle concepts, including LLMs, embeddings, and RAG
- Hands-on experience with AI evaluation tools(e.g., RAGAS, DeepEval, Promptfoo)
- Familiarity with MLOps concepts(model versioning, drift monitoring, model registries)
- Awareness of Responsible AI principles

What You'll Deliver
- High-quality validation documentation and audit-ready packages
- Executed and traceable IQ/OQ/PQ protocols
- Comprehensive risk assessments and validation reports
- AI validation outputs, including drift analysis and adversarial testing reports
- Inspection-ready deliverables supporting regulatory compliance

Why Join Us?
- Work on cutting-edge AI-driven clinical systems
- Be part of a forward-thinking quality and innovation team
- Opportunity to shape AI validation practices in regulated industries
- Collaborative environment with strong regulatory and technical expertise

📌 Validation QA Tester - AI & CSV (Chennai)
🏢 Project Foundry Resourcing Services
📍 Chennai