We’re looking for a Lead CSV / CSA Specialist to drive validation strategy and compliance for cloud-based data platforms, including Azure Databricks, within a GxP-regulated environment.
This is a high-impact opportunity to shape how modern data platforms are validated—moving beyond traditional documentation toward risk-based Computer Software Assurance (CSA) approaches aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11.

? What You’ll Do
Define and lead Validation Master Plans (VMP) for cloud and data platforms
Own CSA-based validation strategies and risk assessment frameworks
Author and review:
URS / FRS / TRS
Risk Assessments
Traceability Matrices
Design IQ / OQ / PQ frameworks for modern technology platforms
Lead validation activities for:
Data pipelines
Analytics workflows
Cloud infrastructure
AI/ML systems (optional)
Define change control and revalidation strategies
Partner with QA, Engineering, and Business teams to ensure compliance by design




Support audit readiness, deviations, and CAPA activities

? What We’re Looking For
8–12 years of experience in GxP-regulated environments (GMP / GLP / GCP)
Solid expertise in:
Computer System Validation (CSV)
Computer Software Assurance (CSA)
Deep knowledge of:
21 CFR Part 11
EU Annex 11
GAMP 5
Experience validating:
Cloud platforms and/or data & analytics platforms
eQMS, LIMS, ELN, or similar GxP systems

⭐ Nice to Have
Exposure to Azure Databricks, Snowflake, or modern data platforms
Understanding of:
IAM / RBAC / SSO
Data lineage and audit logging
CI/CD and controlled releases
Experience with AI/ML validation
Experience supporting regulatory audits and inspections
Knowledge of Data Integrity / ALCOA+
Experience with FMEA-based risk assessments

📌 CSA Specialist (Bengaluru)
🏢 Xander America
📍 Bengaluru