Vaishnavi Dasari Email & Phone Number

With a strong background in identifying root causes and implementing corrective actions for deviations from established protocols, I specialize in analyzing system operations to ensure compliance with SOPs and cGMP guidelines. My experience includes managing change controls, reviewing batch records and master documents, investigating non-compliance findings, and providing quality assurance for deviation investigations.At Project Insulin, I gained hands-on regulatory experience, ensuring compliance with FDA guidelines and regulatory requirements throughout various stages of the project. I was involved in preparing regulatory submissions, reviewing documentation for clinical and pre-clinical phases, and facilitating communication with regulatory bodies to streamline approval processes. I am proficient in executing test protocols, documenting remediation actions, summarizing investigation reports, and delivering project and system-related deliverables to meet both quality and regulatory standards.