Amol Yelgaonkar: The Driving Force Behind Excellence in Quality and Compliance at ProPharma
Impact Recognition: India’s Highly Regarded Quality Leader Of The Year-2024
A prominent figure within the landscape of the pharmaceutical industry, Amol Yelgaonkar, Director of ProPharma, is distinguished for his in-depth knowledge, years of expertise, and deep understanding of industry trends.
Amol carries with him over 27 years of extensive experience in pharmaceutical quality assurance, quality control, auditing, method development and validation, technology and method transfers, medical and regulatory affairs, and operations, working for reputed brands like Searle India Limited (a GD Searle US company), Nicholas Piramal, Glenmark Pharma, SPI Pharma Inc., Unichem Laboratories Limited, Themis Medicare, and Piramal Pharma.
At ProPharma, Amol works as a subject matter expert in quality, compliance, and auditing services and leads the Business Development function in the Indian Sub-Continent. He helps his clients overcome obstacles related to quality and compliance for their export enterprises to ensure that the goods their company produces are safe, effective, and of high quality up until they are administered to the patient.
Amol has been playing a vital role in leading ProPharma to unparalleled milestones and laying the groundwork for future innovation and prosperity with his visionary approach and relentless pursuit of excellence.
In academics, the visionary leader completed his PhD in analytical and herbal chemistry at the University of Bombay after earning a master’s degree in analytical chemistry from the renowned Savitribai Phule Pune University.
Throughout his professional journey, Amol’s diverse roles encompass general manager, vice president, head of quality and regulatory, and other key executive roles in different national and international companies. His expertise encompasses most functions within the industry, including R&D, QC, QA, BE studies, operations, supply chain, and medical and regulatory affairs, spanning the whole product lifecycle from APIs to finished dosage forms.
Through unwavering dedication and relentless hard work, Amol has earned a well-deserved reputation as an esteemed specialist, with the experience of facing over 50 regulatory inspections undertaken by various regulatory bodies like the USFDA, EDQM, MHRA, TGA, MCC, ANVISA, EMA, etc.
Amol’s impressive track record, which includes 300 inspections of R&Ds, laboratories, excipients, APIs, CROs, primary and secondary packaging, sterilizers, supply chains, distribution hubs, warehouses, and manufacturers of finished dosage forms in India, China, Brazil, Malaysia, etc., firmly establishes him as an industry leader.
Amol is a seasoned global executive with expertise who served as a United States Pharmacopoeia (USP) stakeholder for Western India and South Asia from 2008 to 2014. He has contributed to 11 monographs of the Indian Pharmacopoeia and is a life member of the Society for Pharmaceutical Dissolution Science (SPDS).
Amol is a member of the G. N. Khalsa College’s Board of Studies in Matunga, Mumbai, as well as the governing body of the Gahlot Institute of Pharmacy in Navi Mumbai. In addition, he lectures as a guest at several distinguished institutions, including the Institute of Pharmaceutical Management (IPM), GN Khalsa College, Gahlot Institute of Pharmacy, and Vivekanand College of Pharmacy.