Sunil Kumar Singh

About Sunil Kumar Singh

As a Global IT Quality & Compliance Manager at Baxter, I’m proud to work alongside exceptional colleagues who are united by a strong, values-driven culture and an uncompromising focus on Product Quality, patient safety, Data Integrity & Regulatory Compliance. Together, we are redefining healthcare Global IT compliance with various regulations be it 21CFR part-11 or MHRA or PICS or EU Annex-11 or CSA that meet customer or patients\' requirements and help providers deliver better outcomes.I lead a cross-functional ERP team that turns complex project Assignments into value driven solutions by applying deep quality expertise and agile thinking to advance the next generation of healthcare products/Systems. Guided by our culture, I am empowered to collaborate freely and lead my team with trust and courage. What inspires me most is the purpose behind our work—knowing that what we create & support has a direct impact on people’s lives. Outside the work, I recharge by playing cricket, fun with kids, walking around lakes & exploring new ways of learning and love volunteering newcomers about CSV, CSA, CQV and SDLC. I believe innovation thrives in curious, balanced minds—and I bring that spirit to every project I work & lead.I am proud to be a part of a mission-driven organization committed to saving and sustaining lives.#ThisIsWhere my work can change lives.With 15+ years of experience in IT Quality, Computer System Validation (CSV), and regulatory compliance, I specialize in aligning technology initiatives with business and compliance goals in the pharmaceutical & life sciences industry. I have successfully led global IT quality programs, managed ERP & cloud validation projects, and faced over 10 international regulatory audits (USFDA, MHRA, WHO, TGA) with zero critical findings.My expertise spans GAMP-5, 21 CFR Part 11, EU Annex 11, ISO 13485, ERP validation (SAP/JDE), CSA, QMS optimization, and data integrity (ALCOA). I thrive in driving risk-based validation strategies, harmonizing global quality processes, and building strong audit-ready compliance cultures.Currently leading IT Global Quality & Compliance at Baxter Healthcare, I am passionate about enabling organizations to adopt next-gen technologies (cloud, RPA, AI) without compromising compliance integrity.\"Specialties: Dealing with validation activities like Preparation, execution and Review of Qualification protocols like URS, Risk Management, VP, FS/TS, IQ, OQ, PQ, VSR, RTM.To learn more about a career at Baxter, visit jobs.baxter.com

Experience

1. Manager-it Quality & Compliance

   Baxter International Inc.

   Feb 2024 — Present · Bengaluru, IN

   Application assessment got GxP Fitment, Defining Validation roadmap and strategy, Risk Assessment and Management throughout System lifecycle. Critical think Based Validation testing aligned with new Computer Software Assurance (CSA). Scalable life cycle approach for Software Validation.Well versed & championing the 21CFR Part-11, CSA, Annex-11 & GAMP-5 second edition methodologies. ERP system rollout, footprint implementation, integration with internal and external software/third party applications using middleware software platforms. GxP Assessment of ERP application & associated requirements, Warehouse Management System (WMS Swisslog & Witron WCS), Global Manufacturing Excellence software\'s and integration with ERP system, equipment\'s & instruments for Validation need, Change Management within ServiceNow & Remedy, ERP Validation (JD Edwards), Risk Management, Requirements, Test and Defect Management in Micro Focus ALM testing Tool.Authoring, Review and Approval of Validation deliverables like URS, Risk Management (Initial Risk Assessment, Functional Risk Assessment), Functional Specification/Technical Specification/FSDS covering configuration specification, Validation Plan covering Validation strategy & Roadmap, IQ, data Migration strategy and alignment, OQ/User Acceptance, Requirements Traceability Matrix, Validation Summary Report, Risk Management Report.Audit & Compliance covering internal, external and regulatory Audits, Annual IT SOX Compliance covering controls pertaining Application layer, Operating system and Database layer. Governance Risk and Compliance using Archer GRC tool. Data Integrity Assessment and Awareness, Training & Compliance on CSV lifecycle management, periodic review of highly critical systems, Collaboration with cross functional teams.Project management for Software application validation including reporting, timeslines alignment, Milestones alignment and walkthrough on Validation requirements. Resource management across geography.

Education

• Shri G S Institute of Technology & Science

  Master's degree, Medicinal and Pharmaceutical Chemistry

• Subhadra kumar Inter college Basani Varanasi

  Science(10+2), Hindi. English, Mathematics, Physics and Chemistry

  1999 — 2001

• Shri G.S.Institute of Technology and Science Indore

  Master of Pharmacy , Medicinal and Pharmaceutical Chemistry

  2007 — 2009

• Mahatma Jyotiba Phule (MJP) Rohilkhand University, Bareilly.

  Bachelor of Pharmacy - BPharm, Pharmacy

  2002 — 2006

Skills

• Validation
• Documentum
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Life Sciences
• Standard Operating Procedure (Sop)
• Change Control
• Software Development Life Cycle (Sdlc)
• Formulation
• Quality System
• Pharmaceutics
• Sdlc
• Trackwise
• Gamp
• Computer System Validation
• Gmp
• Capa