Bhargavi Hirde

Ace Engineer @Orise

IE

Led and managed a project independently validating over 10 computerized systems in fullcompliance with cGMP, CFR Part 11, Data Integrity and ISO standards. Oversaw the entire validation lifecycle, from system implementation, test script execution to authoring operational SOPs and delivering employee training, ensuring successful system integration and regulatory adherence.• Leading a project as a CSV Engineer for the validation of a custom-built eLogbook application at a pharmaceutical manufacturing site in Dublin• Led Nonconformance and Corrective and Preventive Actions (CAPAs) by conducting root cause investigations, implementing corrective measures, and ensuring timely closure. • Acted as the QA coordinator and stakeholder for the Internal Quality Management System (M-Files), overseeing Audits, OFI, Document Management, Change Control, and Training Management.• Supported and co-audited customers on ISO 9001:2015 and actively contributed to NSAI audits for ISO 9001:2015 and 27001:2017.• Managed an external project, which involved auditing internal QMS, developing new quality procedures, and training over 20 employees.

Nanyang Technological University Singapore

Internship

University College Dublin

MEngSc, Food engineering

Vishwakarma Institute Of Technology

Bachelor of Technology - BTech, Chemical Engineering

Spicer Higher Secondary School

High school

OakPoint middle school

Elementary school