System Validation (CSV) / CSA Consultant

Computer System Validation (CSV) / CSA Consultant

Experience: 4–14 Years

Location: Hyderabad / Bangalore / Chennai / Pune - Hybrid

Work Timing: 12:00 PM – 9:00 PM IST

Job Summary

Looking for an experienced CSV / CSA Consultant with strong expertise in GxP-regulated systems, Computer System Validation, Computer Software Assurance, GAMP 5, data integrity, and risk-based validation. The candidate will support validation activities across Agile, Waterfall, SaaS, cloud, and modern digital platforms within regulated Life Sciences environments.

Must-Have Skills

• Strong experience in Computer System Validation (CSV) / Computer Software Assurance (CSA).
• Good knowledge of GAMP 5, GxP, risk-based validation, data integrity, and ALCOA+ principles.
• Experience across the validation lifecycle including requirements, specifications, risk assessment, traceability, test planning/execution, deviations, change control, CAPA, and audit readiness.
• Experience validating SaaS, cloud-hosted applications, and regulated IT systems.
• Strong understanding of Agile, Waterfall, and hybrid SDLC environments.
• Experience with IQ/OQ, functional testing, user stories, test planning, and validation documentation.
• Knowledge of audit trails, user access, data lineage, interfaces, manual processes, and connected systems.
• Understanding of IT Quality, IT Compliance, IT Risk Management, and Quality Governance.
• Practical knowledge of servers, VMs, storage, databases, load balancers, networks, and cloud service models (IaaS/PaaS/SaaS).
• Strong stakeholder coordination, documentation, delivery management, and risk escalation skills.

Good to Have

• Hands-on experience with JIRA, QTest, ServiceNow, and ValGenesis.
• Experience with eLearning / Learning Management Systems.
• Knowledge of AI/ML system validation, including data quality, explainability, human oversight, drift monitoring, and revalidation.
• Experience developing training materials and eLearning content.
• Exposure to Pharmacovigilance (PV) processes and regulated Life Sciences applications.