Anitha Eapen

Background

About Anitha Eapen

With a solid foundation in Clinical Pharmacy and extensive experience as a Pharmacist in both India and the Middle East (Muscat, Oman), I bring a unique global perspective to healthcare and quality management. I hold both a Bachelor’s and Master’s degree in Clinical Pharmacy from Dr. M.G.R Medical University in Chennai, India, complemented by a Clinical Research certification from Atlanta, Georgia, which has enriched my understanding of both research methodology and regulatory compliance. Currently, I am a Quality Control Inspector at STERIS, where I apply my expertise in quality management to support the safe and effective development of medical devices. My role involves ensuring compliance with ISO 13485:2016 and ISO 9001 standards, leveraging my knowledge of current Good Manufacturing Practices (cGMP) to enforce strict regulatory standards. I am also well-versed in the U.S. FDA’s regulatory frameworks for medical devices, including FDA 21 CFR Part 820, which underpins my commitment to patient safety and product quality. I am passionate about continuous learning and staying updated on the latest advancements in quality management systems and regulatory standards. My experience, dedication, and international work history allow me to bring a well-rounded approach to quality assurance, regulatory compliance, and cross-functional collaboration.