Dr Shalini Suraj
Senior Manager – Quality Assurance
Dr Shalini Suraj is the Senior Manager and in-charge of the Quality Assurance department of Abiogenesis Clinpharm. A professional dentist and experienced GxP Auditor with a total experience of over 15 years, she is responsible for developing and implementing QMS and handling Audits at Abiogenesis.
Dr Shalini has worked in progressively responsible positions in the clinical research environment for more than 13 years. She has worked primarily in the audit domain with expertise in GCP audits. She has a clear awareness of diverse backgrounds; widely varied patient needs and circumstances. Having worked in various positions in clinical research and also with experience of private practice as a dentist, she can relate with Investigators (for medical-related issues), monitors (for monitoring), coordinators (for site activities) and auditors very well. She has a perfect understanding of the various services of all the departments of Abiogenesis.
Dr Shalini has significant experience in Quality Assurance systems covering clients and systems, process validation, CAPA, complaints, audit functions, documentation, and records management. She has experience in planning, coordination, conduct and reporting of Clinical Investigator site audits, client audits, vendor audits (GMP & GLP facilities, vendor qualification audits), document audits, quality systems and processes (internal audits), including for-cause audits per company SOPs and applicable regulations. Her experience also includes managing quality aspects of international GxP projects and provide quality support for GCP related activities for all the functional departments.
Dr Shalini is also responsible for overseeing the departmental training and in-charge of the Abiogenesis LMS.