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
)
- Strong 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 up-to-date 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