Dr. Shalini Suraj
Manager – Quality Assurance
A professional dentist and experience GCP Auditor. Involved in activities pertaining to Quality Assurance in Clinical Research. She has worked in progressively responsible positions in clinical research environment for more than over 7 years. She has Clear awareness of diverse backgrounds, widely varied patient needs and circumstances. Having worked in various positions in clinical research and 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 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.