プロフィール詳細

プロジェクトを作成

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Sachin B.に依頼

Belgium

Pharma GxP: AI Validation, CSV/CSA & Quality Transformation"

プロフィール概要

Senior Pharma Quality & Digital Transformation Leader 25+ years building GxP-compliant systems at scale across Boehringer Ingelheim, Sun Pharmaceuticals, UCB Pharma, and GSK. Core Expertise: AI Validation & Computer Software Assurance (CSA) frameworks Computer Software Validation (CSV) and regulatory readiness Quality Management System (QMS) implementation (Veeva, ValGenesis, MasterControl) Paperless validation and eValidation platforms SAP HANA ERP migration and GxP compliance FDA/EMA inspection preparation and compliance governance Digital quality transformation and process industrialization Track Record: Zero critical findings across 300+ regulatory inspections Built paperless validation platform across 40+ sites (6M paper records/year eliminated) Led 2,000+ server data centre migration with SAP HANA ERP (6 months, full GxP compliance) Delivered 60% speed improvement and 80% reduction in rework across quality processes GAMP Global Steering Committee member; Top 10 Innovator 2024 (AI in CSV) Current Focus: GxP AI validation strategy and governance CSA/CSV transition consulting Validation platform selection and implementation advisory Quality digitalization roadmaps for regulated environments Available for strategy consulting, implementation guidance, inspection readiness assessments, and regulatory compliance advisory.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

• Writing
• Consulting
• Product Development

Writing Technical Writing, Business & Legal Writing

Consulting Business Strategy Consulting, Digital Strategy Consulting, Legal Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

Consultant

Trustbridge Consulting

4月 2026 - 現在

学歴

MBA

Sikkim Manipal University of Health, Medical and Technological Sciences - India

1月 2005 - 1月 2007

認定資格

• Doctor of Business Administration

  ESGCI

  4月 2026 - 現在