UST is looking for an experienced CSV / CSA Lead (Computer System Validation / Computer Software Assurance) to lead validation and assurance activities for GxP-regulated computerized systems across laboratory, manufacturing, quality, and enterprise environments. Experience 10-15+ Years Domain Life Sciences / Pharma / Biotechnology / Medical Devices Location Global Delivery / Hybrid

Key Responsibilities
CSV / CSA Strategy & Governance
• Define and maintain CSV/CSA methodologies, procedures, templates, and governance frameworks.
• Drive adoption of risk-based Computer Software Assurance (CSA) approaches and industry best practices.
• Standardize validation processes across programs, sites, and business units.
• Support the development and maturity of Validation / CSA Centers of Excellence (CoE). Validation Lifecycle Leadership
• Lead the end-to-end computerized system validation lifecycle.
• Develop and review Validation Plans, IQ, OQ, PQ, and Validation Summary Reports.
• Conduct risk assessments and gap analyses.
• Ensure requirements traceability across testing, approvals, defects, and deployment. Regulatory Compliance & Inspection Readiness
• Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ Data Integrity principles.
• Partner with Quality Assurance teams to support regulatory inspections and audits.
• Support CAPA, deviations, remediation activities, and inspection responses.
• Act as a CSV/CSA subject matter expert during audits and regulatory inspections. Data Integrity
• Serve as a Data Integrity SME for regulated computerized systems.
• Ensure effective implementation of audit trails, electronic signatures, user access controls, traceability controls,



and data lineage requirements.
• Assess and mitigate data integrity and compliance risks. Leadership & Continuous Improvement
• Lead validation planning and execution across multiple projects and global teams.
• Collaborate closely with QA, IT, Manufacturing, Laboratory, Quality Systems, and Business stakeholders.
• Identify opportunities for validation automation, standardization, and process optimization.
• Mentor teams and provide guidance on CSA methodology and risk-based decision-making.
• Support digital transformation initiatives involving regulated systems. Required Experience & Skills
• 10–15+ years of experience in Life Sciences and GxP-regulated environments.
• Proven experience leading CSV and CSA programs.
• Solid hands-on understanding of:
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• GAMP 5
• FDA 21 CFR Part 11
• EU Annex 11
• ALCOA+ principles
• Data Integrity
• Risk Assessments
• Requirements Traceability
• CAPA & Deviation Management
• Experience supporting regulatory inspections and audits.
• Strong stakeholder management, communication, mentoring, and leadership capabilities. Systems / Platforms Experience Experience validating one or more of the following:
• LIMS: LabWare, LabVantage, SampleManager
• MES / Manufacturing Systems
• QMS: Veeva QMS, MasterControl, TrackWise
• ERP Systems
• ELN
• CDS
• Laboratory and other GxP-regulated computerized systems Validation Tools Exposure to validation and lifecycle management tools such as:
• ValGenesis
• Kneat
• HP ALM
• Veeva Validation Solutions
• Related validation/quality toolsets

📌 Consultant (Bengaluru)
🏢 UST
📍 Bengaluru