Shirisha Vemani

Validation Technician Ii @Novartis

Indianapolis, IN, US

Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.• Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.• Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Novartis QM, QD and global regulations.• Interact/collaborate with Tech/Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.• Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.• Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.• Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.• Executed CSV support activities for Line 4 Pluvicto manufacturing, including alarm testing, interlock and command verification, user access level control, audit trail review, and hold time studies.• Supported upstream and downstream dry runs and validation addendum execution, ensuring system compliance with GMP and regulatory standards.

Jawaharlal Nehru Technological University

Bachelor's degree, Pharmacy

University of New Haven

Master's degree, Public Health

University of New Haven

Certfication, Healthcare Informatics