Anurag Garg

About Anurag Garg

Quality, Compliance, and QMS LeadershipI am an accomplished professional with a proven track record of delivering over 25 years of career success in Global Quality Assurance (QA), Quality Control (QC), Quality Management Systems (QMS), and overall Compliance, complemented by extensive international exposure across Multiple Dosage Forms such as API, Intermediate Bulk, Oral Solid Dosage (OSD)- Tablets and Capsules, Medical Devices, and Liquid Formulations.Leadership in QA, QMS, and ComplianceMy strengths lie in driving Quality governance, leading cultural transformation and behavioral change initiatives to embed Quality Principles across global manufacturing sites, including FDA Warning Letter Remediation, Data Integrity and CSV (Computerized Systems Validation) remediation projects. I have successfully demonstrated excellence and strategic direction in:• Providing QA leadership at a global level for CSV and Data Integrity standards.• Developing and executing robust Inspection Readiness Programs to prepare sites for regulatory inspections, including USFDA, EU, MHRA, TGA, ANVISA, PMDA, and other health authorities worldwide.Key Expertise in Compliance and Regulatory ReadinessI have consistently delivered superior performance in driving global regulatory compliance and meeting stringent health authority requirements. This includes:• Successfully creating and implementing controls and procedures to comply with 21 CFR Part 11, ensuring data integrity, traceability, and system validation.• Leading FDA 483 Observation & Warning Letter Remediation projects by effectively managing observation responses and implementing sustainable compliance frameworks.• Preparing sites for GMP audits and inspections conducted by international regulatory bodies, such as USFDA, EMA, WHO, MCC, TGA, ANVISA, among others.Key Achievements:• Spearheaded global cultural transformation initiatives to establish and embed Quality & Data Integrity Principles across Novartis sites.• Ensured compliance with evolving GMP regulations to maintain product quality and safety while delivering operational excellence.• Enabled seamless alignment with regulatory standards through the development and implementation of robust QMS frameworks, promoting inspection readiness and governance.

Experience

1. Associate Director Qa Evaluation and Integration - Qms and Compliance

   诺华

   Sep 2024 — Present · Mumbai, IN

   Main responsibilities include leading evaluation of Business Development / licensing and merger & acquisition integration with focus on Quality Management System (QMS) and Compliance. Established cross-functional teams for integration and developed QMS integration plan. Led evaluation efforts of acquired companies via deep dives, gap assessments, and risk management. Ensured Novartis\' QMS and applicable regulations are implemented in acquired companies. Represented Quality Business Development in QMS and Compliance teams. Conducted Data Integrity related activities for integrations including DI training for incoming company. Provided support for implementing and handing over deals to relevant Line Functions. Assisted in Health Authority Inspection readiness programs and internal/external audits. Regular international travel for various Integration workshops attendance. Key performance indicators include efficient and effective management of teams, delivery of QMS cutover within agreed timeframe, successful completion of M&A deals, and satisfactory outcomes in internal audits and inspections conducted by external Health Authorities.

Education

• Chaudhary Charan Singh University (CCSU), Meerut

  Master of Science (MSc), Masters in Organic chemistry

• St Charles Inter College

  10+2 standard, Science

• Chaudhary Charan Singh University (CCSU), Meerut

  Bachelor of Science - BSc, Chemistry

• Birla Institute of Technology and Science, Pilani

  Master of Technology - MTech, Pharmaceutical Operations and Management

• St. Charles Inter College, Sardhana, Meerut

  10th Standard

• InfoTech Computer Education, Meerut (U.P.)

  Diploma in Software and Programming, Computer applications

  1998 — 1999

Skills

• Uv/Vis
• Glp
• Quality Auditing
• Quality Assurance
• Regulatory Affairs
• Hplc
• Formulation
• Technology Transfer
• 21 Cfr Part 11
• Capa
• Gmp
• Dissolution
• Anda
• Sop
• Fda
• Regulatory Requirements
• V&V
• Regulatory Compliance and Commercial Support
• Generic Programming
• Cleaning Validation
• Validation
• Change Control