Prabhakar J Email & Phone Number

Digital Transformation Professional with over 20+ years of extensive experience in quality processes, IT Quality, and Computerized Systems Validation (CSV) within the pharmaceutical sector, I bring a deep expertise in developing and implementing Quality Assurance Strategies and Policies. Additionally, I have a strong background in managing all aspects of the IT Service Life Cycle, ensuring alignment with industry standards and best practices. My areas of expertise include:o Quality Process Design: Spearheaded the design and development of Quality processes for the Software Development Life Cycle (SDLC) and Computer System Validation, ensuring compliance with industry standards.o Quality Oversight: Led the IT Quality function to ensure that all operational activities of GxP systems, including changes, periodic reviews, and deviations, are fully compliant with organizational policies and regulatory standards.o Application Development: Extensive experience in developing a wide range of pharmaceutical applications, including Quality Management Systems, Document Management Systems, Warehouse Management Systems, and eLog Management. Additionally, I have been actively involved in the development of applications leveraging Generative AI and various Large Language Models (LLMs), which are increasingly essential in the pharmaceutical industry. Approach centers on design thinking, ensuring that these solutions are both practical and aligned with user needs and industry standards.o Product Management: Successfully acted as a product manager for various GxP systems, delivering innovative solutions to businesses through the adoption of Agile Methodologies.o Global Rollouts: Experienced in Global Application rollouts, ensuring Lifecycle Management adheres to policies, SOPs, and procedureso Lifecycle Management: Responsible for end-to-end Lifecycle Management of GxP applications, ensuring compliance with relevant guidelines and regulations such as GAMP, 21 CFR Part 11, EU Annex 11 etc.o Audit Management: Led over 100+ regulatory and customer audits, including USFDA (15), MHRA (7), TGA (5), ANVISA (5), WHO, CDSCO (8), and 75 customer audits, focusing on Quality Systems, IT Systems, validations, and documentation controls.o Business Analytics: Designed and developed quality analytics and dashboards to track business KPIs, leveraging data for predictive and prescriptive analytics.o Leadership Skills: An effective team leader with a proven ability to initiate and manage cross-functional teams and multidisciplinary projects.