Ms. Lakshmi Achuta is a Quality Assurance professional with over two decades of experience in the Biotechnology, Biopharmaceutical, Clinical Research Organization (CRO), Contract Research and Manufacturing Services (CRAMS) industries having initiated her career at Biocon in 1993 and subsequently worked in Clinigene and Syngene. She is experienced in implementing, aligning processes, upgrading Quality Systems and pertinent Management Standards and regulatory requirements (GXP) (Laboratory Management System, EHS Management System, Information Management System) that enabled personnel to function effectively, improving efficiency across interfacing stakeholders.
Lakshmi has established the Medical Devices Quality Systems and Development Quality Assurance. She has to her credit establishing the Quality Assurance department, inclusive of Clinical Quality Assurance; and, developed a strategy for harmonizing and centralizing the Quality Systems to align with the Clinical Research industry best practices and relevant regulatory requirements to enhance the CRO’s capability as a full service CRO. She brings with her the experience spanning disparate systems with the proficiency to integrate / align requirements as per Regulatory norms; train and mentor QA and auditors on auditing various systems per regulatory requirements. She has hosted various National and International inspections from Regulators, Certifying Agencies and Accreditation bodies. She is qualified with M.Sc. in Applied Botany (Medicinal and Aromatic Plants) from Bangalore University and M.S. in Quality Management from BITS, Pilani.