Santhosh B
CSV/CSA | Digital Transformation | GxP | Regulatory Compliance | Data Integrity | Quality & Compliance Consulting in Regulated Industries
- Role
- Associate Consultant - Ls Domain Consulting at Infosys
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Santhosh B
Computer System Validation (CSV) and IT Quality professional with 3+ years of experience in regulated life sciences environment, supporting implementation & enhancement projects, and operational validation of GxP systems.I specialize in risk-based validation strategies, SDLC compliance oversight, and maintaining audit-ready systems aligned with global regulatory expectations. Core Expertise in Regulated Environments- End-to-end validation lifecycle ownership (IRA → FRA → OQ/PQ → RTM → VSR)- Validation planning for implementation and change control projects- Risk-based validation aligned with GxP and data integrity principles- SDLC deliverable review and quality oversight- Periodic Review & Audit Readiness Support- Change Management & Revalidation Strategy- Vendor assessment and compliance documentation support- Exposure to cloud-based systems and AI/ML validation concepts Experience Across GxP Systems - Hands-on validation and compliance experience in: TrackWise (On-Premise), Argus Safety, Regulatory Information Management Systems (RIMS), Signal Management Systems, Document Management & Training Management Systems (DMS / TRMS), Business Intelligence & Quality Analytics Platforms, Traceability & Automation Tools Validation & Quality Management Platforms - GoVal, JIRA, ALM, ServiceNow, SAP, Confluence, Enterprise Document Management Systems Professional Focus- Focused on advancing risk-based Computer System Validation within regulated life sciences while expanding into emerging areas such as AI/ML validation, cloud platforms, and digital validation transformation- Committed to ensuring evolving technologies are implemented with strong compliance frameworks, data integrity controls, and sustained audit readiness aligned with global regulatory expectations.
Experience
Associate Consultant - Ls Domain Consulting
Aug 2025 — Present · Chennai, IN
Education
P.S.R Engineering College, Sivakasi - 626 140
Bachelor of Technology - BTech, Biotechnology
2018 — 2022
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