Hardik Mistry has recently joined Otsuka Pharmaceutical India Pvt. Ltd. as Quality Assurance S. Manager. Based in Ahmedabad, Gujarat, he will be leading key areas such as quality operations, project execution, product development through commercialization, facility design and build-up, validation and qualification, and quality system support.
\Before joining Otsuka Pharmaceutical India Pvt. Ltd., Hardik Mistry served as QA Qualification Head at Troikaa Pharmaceuticals Ltd. from February 2021 to October 2025. At Troikaa, he led the Quality Assurance Validation department, managed qualification master plans, and ensured regulatory compliance for GMP equipment and computerized systems while driving continuous improvement in quality processes.
Earlier in his career, Hardik Mistry worked as Ast. Manager – Projects & Quality Assurance at Hester Biosciences Limited from February 2017 to February 2021, where he managed QA functions, internal and supplier audits, validation protocols, and quality management systems. He also contributed to project quality management for new facilities and oversaw compliance with ISO and GMP standards.
From January 2015 to February 2017, Hardik Mistry was Executive Quality Engineering at Sun Pharma, handling qualification master plans, equipment validation, HVAC systems, and deviation and CAPA management. His earlier experience includes roles as Sr. Executive QA and Executive QA at Hester Biosciences Limited, and Analyst Bioanalytical/Bioequivalence at Torrent Pharmaceuticals Ltd., where he developed expertise in chromatogram review, GLP documentation, and equipment calibration.
Hardik Mistry is an alumnus of L.M. College of Pharmacy, Ahmedabad. His career reflects more than a decade of excellence in quality assurance, validation, regulatory compliance, and pharmaceutical manufacturing operations across leading Indian pharmaceutical companies.