Amrita Naidu
Senior Quality Assurance Specialist @Cliantha Research Limited
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WORK HISTORY
Senior Quality Assurance Specialist @Cliantha Research Limited
Toronto, ON, CA
EDUCATION
The University of Texas at Arlington
Master of Science (MS), Biology
The University of Texas at Arlington
Bachelor of Science (BS), Microbiology
SKILLS
ABOUT AMRITA NAIDU
Quality & Regulatory Compliance professional with 14 years of experience spanning clinical research, drug bioanalysis, and regulated laboratory environments. Expertise in supporting global clinical trials within CRO settings, specializing in BA/BE and pharmacokinetic (PK) studies under cGCP and cGLP frameworks. Proven success in driving audit and inspection readiness aligned with FDA, EMA, ICH, and Health Canada requirements, with strong capabilities in QMS development, CAPA management, and risk-based compliance. Collaborative partner to cross-functional teams, recognized for strengthening quality culture, ensuring data integrity and subject safety, and delivering continuous improvement across global operations.
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