He holds a master’s degree in sciences from Bharathidasan University, Trichy, Tamil Nadu, boasts over two decades of extensive experience in Quality Assurance within the pharmaceutical industry. His deep expertise spans both Quality Assurance and Development Quality Assurance, ensuring compliance with ICH guidelines, GMP, cGMP, regulatory norms and International Standard Organization (ISO) Quality Systems.
He is proficiency in Quality Assurance encompasses critical areas such as 21 CFR Part 211, Data Integrity and Reliability and Quality Compliance Training. He is highly skilled in implementing and managing Quality Management Systems (QMS) and Quality Risk Management (QRM), ensuring robust quality control throughout the pharmaceutical development process.
His ability to oversee comprehensive Project Management functions is well-demonstrated, including meticulous project planning and providing support for formulation developments, particularly in relation to quality assurance for regulatory filings such as ANDA, Pre-ANDA, Para-IV, EU and ROW markets.
His extensive experience is further highlighted by his active participation in numerous regulatory and customer audits conducted by leading agencies such as USFDA, MHRA, Health Canada, TGA, PMDA, WHO, ANVISA, UGANDA and MCC. His involvement in these audits showcases his deep understanding of regulatory compliance and quality standards.
His expertise in navigating and meeting stringent quality requirements has made him a valuable asset in the pharmaceutical industry, ensuring that all products meet the highest standards of quality and safety