Validation Lead – AI Product Quality & Compliance

- Location: Bangalore, India (full-time, on-site)
- Experience: 12-15 years
- Department: Quality / Product Validation
- Works with: Product, Development, QA, Regulatory/Compliance and SMEs
- Company : Klarixa Private Limited (a subsidiary of Pharma Tek Solutions, USA)
- Compensation: Competitive salary + meaningful equity from Day 0
- Location: BHIVE Workspace – HSR Campus, Hosapalaya, Bangalore (In-Office)

Company Website: http://www.klarixa.ai Disclaimer: Please apply only if you meet the following experience & qulification criteria.

Required qualifications.

- Bachelor’s degree in engineering, Computer Science, IT, Pharmacy, Life Sciences or a related field .
- 12-15 years in CSV/CSA, software validation or QA in a regulated (pharma, biotech, medical device ) setting.
- Working knowledge of GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ and CSA.
- Hands-on authoring and review of validation plans, risk assessments, test cases, RTM and summary reports.
- SDLC and Agile/Scrum experience; strong technical writing; able to run validation independently.

Preferred experience

- Validating SaaS, web-based or multi-tenant pharma applications .
- E-records and signatures, audit trail, role-based access, workflow, document management or eQMS applications.
- AI/ML or LLM-enabled system validation, APIs and integrations.
- Test automation and tools such as Jira, Confluence or Azure DevOps.

Core competencies.

- Constructively challenges requirements and test coverage, clear written and verbal communication.
- Attention to detail, ownership and accountability.
- Comfortable in a fast-moving startup workplace:



hands-on and flexible on priorities.

Role summary Klarixa is hiring a hands-on Senior Validation Engineer to own risk-based validation of its AI-enabled software product, from requirements through release and ongoing lifecycle. You will ensure the product is built, tested and released to GxP, data integrity and CSA expectations, and stays inspection ready.

Key responsibilities

- Validation strategy: Define risk-based validation scope and strategy for each module, feature and release, and embed validation in the SDLC and Agile sprint cycles, including planning and backlog refinement.
- Risk-based CSA: Apply GAMP 5 and CSA to set testing depth and focus on critical, data-integrity-impacting functions.
- Requirements and traceability: Review requirements for testability and maintain traceability across requirements, risks, tests, defects and evidence.
- Testing and deliverables: Own the validation plan, risk assessment, test strategy and scripts, RTM and summary reports. Oversee execution and review evidence.
- Release and change: Assess validation impact of changes, defects and hotfixes, set regression scope for frequent Agile releases, and approve release evidence. Support CAPA.
- Compliance and audits: Keep Part 11,



Annex 11 and ALCOA+ controls verified, documentation inspection-ready, and support customer audits.
- Improvement: Build reusable templates, test assets and automation, and mentor junior team members.

AI validation responsibilities

- Define acceptance criteria and performance metrics for AI features, aligned to intended use and risk .
- Assess training and test data quality and bias; specify explainability and human-in-the-loop controls.
- Test non-deterministic behaviour with defined tolerances and repeatable test sets.
- Set up drift monitoring and change control for model, prompt and LLM updates.
- Align with GAMP 5 (2nd ed.), ISPE AI guidance, draft EU Annex 22 and FDA AI/CSA guidance.

About Klarixa : Klarixa AI is building an AI-native quality and compliance platform for Pharmaceutical, Biotech, and other GxP-regulated life sciences companies. Its flagship product, KlariFlow, is a Paperless Validation System that uses AI agents to streamline computer system validation and compliance documentation, with human review and approval built into the process to ensure audit-ready outputs.

Klarixa is built on 26+ years of hands-on GxP auditing, computer system validation, and pharma quality expertise. Our founders combine deep AI/SaaS engineering capabilities with frontline life sciences experience, including 200+ audits across FDA-, EMA-, and MHRA-regulated environments.

Klarixa AI is a subsidiary of Pharma Tek Solutions Inc., an established life sciences consulting firm, giving Klarixa access to deep regulatory expertise and strong industry relationships.

📌 Senior Validation Engineer (Bengaluru)
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