Manish Pathodiya

About Manish Pathodiya

With over 15 years of experience in the industry. My expertise lies in ensuring the highest standards of quality and regulatory compliance in the manufacturing of API, OSD, Parenteral, Topical and Liquid formulations. As a seasoned GMP auditor, I have conducted more than 100 audits for API, KSM, and Formulation manufacturing units, consistently delivering outstanding results.Project Management and Greenfield Plant Setup: I possess exceptional project management skills and have led the successful setup of five greenfield pharmaceutical plants. From the initial design phase to full-scale commercialization, I have demonstrated a keen ability to oversee complex projects, ensuring they meet all regulatory requirements and quality standards. Notably, I played a pivotal role in establishing a greenfield project in Greece (Europe), showcasing my international experience and adaptability in navigating diverse regulatory landscapes.Regulatory Compliance and Audit Excellence: My commitment to regulatory compliance is unwavering, as evidenced by my track record of assisting Intas manufacturing sites in maintaining GxP compliance. My achievements include consistently achieving zero critical and major observations in regulatory audits by esteemed bodies such as the USFDA and MHRA. I have also been instrumental in assisting Intas Third-Party manufacturing sites in obtaining timely regulatory product approvals.Quality Culture Transformation and Continuous Improvement:I have been at the forefront of driving transformations within organizations to cultivate a strong and preventive Quality culture. My leadership has resulted in substantial upgrades to Quality management systems, fostering a proactive approach to quality control. I have also spearheaded comprehensive remediation efforts for manufacturing plants, ensuring that they meet and exceed industry standards.Beyond my professional achievements, I have a rich and fulfilling personal life. I am an avid traveler, exploring diverse cultures and expanding my horizons. In summary, I am a dedicated person with a remarkable track record in GMP auditing, project management, regulatory compliance, and quality culture transformation. My commitment to excellence extends beyond the workplace, as I balance my professional achievements with a vibrant and diverse personal life. I am poised to continue making significant contributions to the pharmaceutical industry and look forward to new challenges and opportunities in the field.

Experience

1. Sme - Regulatory Compliance

   Dr. Reddy's Laboratories

   Jul 2025 — Present · Hyderabad, IN

Education

• B. U. Jhansi

  M Pharm., Pharmaceutics

  2007 — 2009

• B.N. college of pharmacy

  B. Pharm, Pharmacy

  2002 — 2007

• National Institute of Business Management (NIBM) Global

  Master of Business Administration - MBA, Material Management

  2007 — 2009

• Indian Institute of Technology, Kharagpur

  Six Sigma

  2021 — 2021

• Nirma University

  Doctor of Philosophy - PhD, Pharmaceutics and Drug Design

Skills

• Glp
• Pharmaceutical Industry
• Sop
• Regulatory Affairs
• Gmp
• Quality Assurance
• Cleaning Validation
• Pharmaceutics
• Validation
• Technology Transfer