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Shalini

Dr. Shalini Suraj

Manager – Quality Assurance

Dr. Shalini Suraj is the Manager of Quality Assurance department of Abiogenesis Clinpharm. A professional dentist and experienced GCP Auditor, she is responsible for the development and implementation of QMS activities in Abiogenesis. Dr. Shalini has worked in progressively responsible positions in clinical research environment for more than over 12 years. She has clear awareness of diverse backgrounds; widely varied patient needs and circumstances. Having worked in various positions in clinical research and also with an 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.

Dr. Shalini has significant experience of Quality Assurance systems covering clients and system, process validation, CAPA, complaints, audit functions, documentation, and records management. She has experience of planning, coordination, conduct and reporting of Clinical Investigator site audits, client audits, vendor audits (GMP & GLP facilities), document audits, quality systems and processes (internal audits), including for cause audits in accordance with company SOPs and applicable regulations.

She is responsible for developing audit plans and reports and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible department/auditee, as needed. Her experience also includes managing quality aspects of international GXP projects and provide quality support for GCP related activities for all the functional departments.