Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist
Location: Hyderabad, Bengaluru, Chennai, Pune
Experience: 5+ Years
Employment Type: Contract 2 hire
Job Summary
We are seeking an experienced Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist to support validation, compliance, and quality assurance activities for GxP-regulated systems within a Life Sciences setting. The ideal candidate will possess strong expertise in risk-based validation methodologies, GAMP 5, CSA principles, data integrity, and regulated software delivery practices across cloud, SaaS, and enterprise applications.
The role will partner closely with Quality, Compliance, IT, Business, and Vendor teams to ensure systems remain validated, inspection-ready, and compliant with regulatory requirements while supporting modern agile delivery models.
Key Responsibilities
Own validation strategy, risk assessments, validation scope, and testing approaches using GAMP 5 and Computer Software Assurance (CSA) principles, focusing on patient safety, product quality,



and data integrity.
Lead end-to-end validation lifecycle activities for GxP-regulated systems, including requirements management, specifications, traceability, testing, deviations, change control, CAPA support, and audit readiness.
Apply GxP regulations, GAMP 5 methodology, and CSA principles across traditional, agile, SaaS, cloud-hosted, and modern digital platforms.
Evaluate supplier documentation and vendor testing evidence to determine appropriate leverage based on risk, intended use, vendor assessment, release impact, and quality agreements.
Support Infrastructure Qualification (IQ), Operational Qualification (OQ), Computer System Validation (CSV), Computer Software Assurance (CSA), risk assessments, IT quality, compliance, and governance initiatives.
Participate in both Agile and Waterfall Software Development Lifecycle (SDLC) activities.
Assess and validate data integrity controls, i

📌 Computer System Validation (Hyderabad)
🏢 Dreampath Services
📍 Hyderabad