Niranjani Nalvazhi

Background

About Niranjani Nalvazhi

As a Validation Manager (VM), I specialize in overseeing the Computer System Validation (CSV) lifecycle, ensuring compliance with critical regulations such as GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5. My expertise includes preparing Validation Plans, performing thorough Risk Assessments, and developing Traceability Matrices to ensure adherence to regulatory standards. I manage the development and execution of test objectives and test scenarios, along with overseeing the Defect Life Cycle, while ensuring all necessary documentation, such as Validation Summary Reports, is meticulously maintained. With a focus on GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), and the strict adherence to SOPs (Standard Operating Procedures), I ensure that clinical, manufacturing, and reporting systems comply with the highest quality and regulatory standards. I also excel in leading teams, managing client communications both offshore and onsite, and delivering robust validation solutions in complex, regulated environments. My leadership and technical expertise ensure the smooth execution of validation activities while maintaining compliance and quality at every step.