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UST is looking for CSV / CSA Lead (Computer System Validation & Computer Software Assurance Lead)

Experience 10-15+ Years

Domain Life Sciences / Pharma / Biotechnology / Medical Devices Location Global Delivery / Hybrid

Role Summary The CSV / CSA Lead is responsible for leading validation and assurance activities for GxP-regulated computerized systems across laboratory, manufacturing, quality, and enterprise platforms. The role provides strategic and operational leadership for Computer System Validation (CSV), Computer Software Assurance (CSA), Data Integrity, Risk Management, and Regulatory Compliance initiatives. The individual will establish validation strategies, govern validation execution, guide CSA adoption,



ensure inspection readiness, and partner with Quality, IT, Manufacturing, Laboratory Operations, and Regulatory stakeholders to deliver compliant and audit-defensible systems. Key Responsibilities CSV / CSA Strategy & Governance • Define and maintain CSV and CSA methodologies, procedures, templates, and governance frameworks. • Drive adoption of risk-based CSA approaches and validation best practices. • Establish standardized validation processes across programs, sites, and business units. • Support development of Validation and CSA Centers of Excellence (CoE). Validation Lifecycle Leadership • Lead the complete validation lifecycle for computerized systems. • Develop and review: • Validation Plans • IQ, OQ, PQ • Validation Summary Reports • Conduct and facilitate risk assessments and gap analyses. • Ensure complete requirements traceability through testing, approvals, and deployment. Computer System Validat

📌 Architect I (Pune)
🏢 UST
📍 Pune