Gyan Prakash Rai

Seasoned IT professional with over 9 years of extensive experience in validating GxP-critical IT systems, including documentation creation, review, and approval of CSV deliverables. Agile Project Management, Application Management, and IT Infrastructure Management. Adept at driving end-to-end service lifecycle management, including service development, design, transition, and delivery, using both Agile/Scrum and Waterfall methodologies.

Seasoned IT professional with over 9 years of extensive experience in validating GxP-critical IT systems, including documentation creation, review, and approval of CSV deliverables. Agile Project Management, Application Management, and IT Infrastructure Management. Adept at driving end-to-end service lifecycle management, including Service Development, Design, Transition, and Delivery using both Agile/Scrum and Waterfall methodologies., GxP Compliance & Computer System Validation (CSV), Operations Management, Stakeholder & Relationship Management, Methodology-Driven Execution

Ensuring adherence to GxP (GMP, GLP, GCP), FDA 21 CFR Part 11, EU Annex 11, and other global regulatory standards for IT systems in pharmaceutical and life sciences industries, managing audits and inspections (internal, external, regulatory) with a focus on compliance, risk mitigation, and corrective actions, end-to-end ownership of IT service lifecycle, including design, transition, delivery, operations, and continual service improvement (CSI), FinOps and cloud cost optimization: managing cloud financial operations (FinOps) via Apptio, including license renewals, budget forecasting, and cost governance for cloud accounts, expertise in computer system validation (CSV), GAMP 5, and risk-based validation for GxP-regulated systems, strong background in quality assurance (QA), ensuring IT systems meet compliance, security, and performance standards, leading projects using Agile (Scrum/Kanban) and hybrid (Agile-Waterfall) methodologies for efficient and compliant delivery, stakeholder and vendor management: building strong relationships with global clients, cross-functional teams, and regulatory bodies across different regions and cultures, proactive risk management, including identification, assessment, and mitigation strategies, structured change management processes to ensure minimal disruption while maintaining compliance, developing and maintaining validation deliverables (URS, FS, DS, RA, IQ/OQ/PQ, SOPs) to meet regulatory and audit requirements

• Quality Management of Computer Systems
• Scaled Agile Framework (SAFe) Certification
• Pharmaceutical Industry Fundamentals (HERAX Pharma Introduction Course)
• Drug Manufacturing & Supply Chain Management
• Good Documentation Practices (GDP)
• IT Governance & Compliance (IT Code of Conduct, IT Systems Management)
• Life Sciences Industry Fundamentals
• 21 CFR Part 11 Compliance & Electronic Records
• Software Validation & Compliance (General Principles of Software Validation, Computerized System Validation SOP)
• Certified Computer System Validation (CSV) Practitioner

• Father's Name: Krishana Mohan Rai
• Date of Birth: 07/04/93
• Nationality: Indian
• Marital Status: Married