Location:
Bengaluru | Employment Type: Full-time | Reports to: CSV Head |

Experience:
7–10years About Ninestars Ninestars is an AI-first automation company serving 50+ enterprise customers across life sciences, pharma, BFSI, media and government. Our AOTM Life Sciences portfolio delivers artwork and labelling automation, regulatory intelligence, proofing and design systems into GxP-regulated environments. Learn more: https://www.ninestarsglobal.com/

About the Role
This is the hands-on core of the validation function. You will build and run the validation framework for AOTM Life products — writing the documents, executing the assessments, training the teams, and standing in front of customer auditors to explain all of it. You are the person who turns a compliance strategy into artefacts that survive contact with a pharma auditor.

Key Responsibilities
Build the Validation Framework
• Conduct baseline CSV and GxP gap assessments across software, cloud and AI/ML components
• Author and maintain core CSV documentation: CSV Policy, system inventory and GxP impact assessment, Validation Master Plan, URS, risk assessment procedures and validation summary reports
• Define intended use statements and GAMP 5 categorisation for each product and component
• Maintain traceability through the RTM: URS → specifications → risk assessment → IQ/OQ/PQ → release evidence
• Build reusable validation packages, each new customer implementation starts from a qualified baseline Execute the Lifecycle
• Author, execute and peer-review test protocols and scripts (IQ/OQ/PQ), pre
- and post-execution
• Perform periodic review: audit trail and access review, incident and change history, backup and restore, patch management, disaster recovery and revalidation decisions




• Assess GxP impact of change and incident records; gate releases on validated-state impact
• Manage deviations and CAPA end to end — investigation, root cause analysis, corrective action and effectiveness check Audits, Customers & Training
• Complete and defend customer CSV questionnaires and supplier assessments
• Prepare for, host and support pharma customer audits; drive remediation to closure
• Run mock audits and inspection-readiness drills; coach engineering, DevOps and delivery teams on how to be audited
• Deliver GxP, data integrity and CSV awareness training; own the training matrix and records Security & AI Validation
• Contribute to the ISO/IEC 27001:2022 internal audit programme as a certified Lead Auditor
• Assess and document Part 11 technical controls: access management, audit trails, electronic signatures, retention and time stamps
• Apply validation controls to AI and agentic components — human-in-the-loop checkpoints, model change control and output verification Mandatory Skills & Experience
• 7–10 years in Computer System Validation, GxP compliance, IT QA or IT audit within life sciences
• Hands-on authorship of VMP, URS, risk assessments, IQ/OQ/PQ and RTM — written, not only reviewed
• Solid working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity
• Practical experience with periodic review, change control, deviation and CAPA management in a regulated environment
• Direct participation in pharma supplier audits, on either side of the table




• ISO/IEC 27001:2022 Lead Auditor certified, or able to certify within three months of joining
• Hands-on with at least one validated enterprise platform — Veeva Vault, LIMS, eLN, DMS, SAP or equivalent
• Excellent technical writing: clear, traceable, defensible documentation Desirable Skills & Experience
• SaaS, cloud platform or enterprise software validation
• AI/ML systems from a validation or governance perspective; exposure to NIST AI RMF or ISO/IEC 42001
• CSA (Computer Software Assurance) applied in practice
• Test management tooling: qTest, HP ALM, IBM RQM, Jira or Azure DevOps
• ITIL Foundation or practical ITSM experience (ServiceNow or equivalent)
• Certified investigator or certified trainer status for RCA, CAPA, GxP or data integrity
• Exposure to ISO 9001, GDPR or HIPAA
• Agile / DevOps release models in a validated environment Certifications Preferred: ISO/IEC 27001:2022 Lead Auditor
· CSV or GAMP 5 credential Desirable: NIST AI RMF Foundation
· ITIL Foundation
· ASQ CQA Ideal Candidate Traits
• Highly pragmatic and execution-oriented; comfortable building from zero
• Confident in audits and customer-facing conversations
• Robust documentation discipline without documentation obsession
• Teaches well — much of this role is making other teams audit-ready
• Works independently and closes loops without being chased Why Join Us
• Zero-to-one. Design the frameworks, documentation and audit readiness from scratch
• Front-row visibility. Partner with the CTAO and CBO during first pharma engagements
• Future-proof skill set. Work at the intersection of AI, cloud and life sciences compliance
• Accelerated growth. Clear runway into the CSV Head and senior GRC track

📌 CSV Lead — GxP Validation (Bengaluru)
🏢 Ninestars Information Technologies
📍 Bengaluru