Deekshith M S
Consultant - Risk Advisory (Life Sciences) | CSV & Data Integrity Expert | SAP, TrackWise & Cloud Validation | Ex-Accenture
- Role
- Consultant at Deloitte
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Deekshith M S
Strategic Risk Advisory Consultant & CSV Subject Matter Expert with a proven track record of orchestrating complex validation lifecycles for Fortune 500 pharmaceutical conglomerates. Currently spearheading GxP risk strategies at Deloitte, I bridge the gap between technical IT complexities and audit-ready regulatory compliance.My expertise lies in navigating the intersection of Technology, Quality Assurance, and Regulatory Compliance. I don\'t just validate systems; I design \"Right First Time\" quality frameworks that accelerate digital transformation while ensuring strict adherence to FDA 21 CFR Part 11, EU Annex 11, and Data Integrity standards.High-Impact Achievements:Strategic Transformation: Leading the shift from document-heavy CSV to modern Computer Software Assurance (CSA), cutting documentation overhead by 40%.Global Delivery: Managed validation for greenfield SAP S/4 HANA and TrackWise deployments across North America and Europe.Process Efficiency: Reduced test execution time by 30% through risk-based functional assessments (GAMP 5).Digital Innovation: Spearheaded a paperless validation rollout (ValGenesis) that improved internal efficiency by 50%.Core Competencies:Regulatory Frameworks: FDA 21 CFR Part 11, EU Annex 11, GAMP 5 (2nd Ed), ICH E6, ISO 13485, GDPR.Validation Expertise: CSV, CSA, Data Integrity (ALCOA+), Cloud Validation (SaaS/IaaS), Audit Defense.Enterprise Systems: SAP S/4 HANA, TrackWise QMS, Veeva Vault, ValGenesis, LIMS, Documentum.Risk Management: FMEA, Gap Analysis, Remediation Planning, GxP Assessment.I am passionate about driving digital quality transformation. Open to connecting with Life Sciences leaders discussing the future of GxP compliance and cloud validation.
Experience
Consultant
Oct 2025 — Present · Bengaluru, IN
Consultant - Risk Advisory (Life Sciences) Company: Deloitte Dates: Oct 2025 – PresentDelivering strategic risk assurance and validation services to top-tier Life Sciences clients, acting as the primary bridge between business units and IT delivery.Strategic Governance: Define and enforce the Corporate CSV Master Plan for global clients, ensuring a standardized risk-based approach across multi-geography manufacturing sites.* Cloud Regulatory Advisory: Guide Digital Transformation initiatives, specifically the migration of legacy GxP workloads to AWS/Azure clouds while maintaining strict 21 CFR Part 11 compliance.* Data Integrity Remediation: Lead high-stakes Data Integrity (DI) assessments for laboratory systems, identifying critical audit trail gaps and designing a 12-month remediation roadmap.Audit Defense & CSA: Prepare client Quality teams for FDA/MHRA inspections via mock audits. Spearheading the transition to Computer Software Assurance (CSA), successfully reducing documentation overhead by 40%
Education
Sri Siddhartha Institute of Technology
Bachelor of Engineering - BE, Electrical and Electronics Engineering
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