Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Amol Yelgaonkar, Director, Quality & Compliance, India
What do you do at ProPharma? How does your role support improving the health and safety of patients?
I manage the Quality & Compliance Operations in the Indian Sub-Continent at ProPharma, and act as a subject matter expert in quality, compliance, auditing services and lead the Business Development function.
We help our clients overcome challenges related to quality assurance and compliance for their export businesses and help them ensure that the products that they develop and manufacture retain their safety, quality and efficacy until they are administered to the patient.
What is one lesson you've learned in this industry that has most helped you?
Over the last 6 decades, the pharmaceutical industry in India and around has gone through many changes. The expectations of regulators are increasing day-by-day, and the environment has been very dynamic. The principle take home over the years has been to learn from previous non-compliances and failures, understand that maintaining safety, efficacy and quality of drugs is a continuous effort. We at ProPharma thrive to put patient safety first.
What do you like best about working with clients?
I have been fortunate enough to work in varied fields of pharmaceutical industry. I have had the privilege of working in R&D, quality control, quality assurance, production, auditing, BE studies, regulatory affairs, operations and I have managed large team sizes as well. Due to this I have been exposed to the entire product life cycle and it surely adds value to my knowledge.
Having this synopsis of the entire product lifecycle enables me to better understand a client's needs and allows me to deliver work considering all other aspects of compliance and regulatory requirements. In fact, when I am responsible for quality and compliance, I can very well talk to the clients about other business verticals of ProPharma and can also deliver work in a few of them.
Tell us a little bit about yourself outside of work.
I am an avid trekker. I have done more than 100 treks in various parts of Western and Northern India. Apart from this I have a passion for photography and have been a wildlife and portrait photographer since last 7-8 years. I have been pursuing my passion for music through singing and instrumental music. I have also started running marathons this year.
What value does a client gain by working with ProPharma's Q&C experts?
ProPharma's compliance consulting professionals with their rich and varied experience will not only identify potential risks in your overall compliance journey but will work as a part of your team to deliver higher levels of quality and regulatory compliance within your organization. The Q&C team will be involved right from early development stage till post commercial activities like UK/EU batch release, QP/RP/RPi services. We can take up remediation work, qualify the entire vendor and supply chain, auditing services, quality investigations, CAPA support, technology transfers, commissioning, qualifications, and validations. To summarize, the Q&C teams can involve themselves at almost each stage of drug development and commercialization and provide a client with suitable solutions to reach market earlier.
