Dr. Shalini Suraj

QA professional with over 15 years of experience in the clinical research industry and over 12 years as an Auditor. A professional dentist, who has worked through progressively responsible positions in the Clinical Research industry. Extensive experience in clinical quality and across major therapeutic areas with a strong focus on Good Clinical Practice (GCP) auditing. Comprehensive experience in conducting GCP and GxP audits across a variety of study types, including IND, ANDA, Phase 1 to Phase 4, BA/BE, and medical device studies and vendor qualifications. Successfully established and led QA department, implementing robust Quality Management Systems (QMS) and Learning Management Systems (LMS).