Hemangi Patil

About Hemangi Patil

With over 5 years of dedicated expertise in Computer System Validation (CSV) and Software Development Life Cycle (SDLC), I bring a wealth of experience to the Life Sciences, Pharmaceutical, and Medical Device Industry. Throughout my career. My strengths lie in analyzing requirements, meticulously drafting and reviewing validation deliverables, and executing precise test cases using tools like JIRA, HP ALM, Qtest, VEEVA Vault. Proficiency in maintaining documentation and upholding testing practices is complemented by my knowledge of industry standards such as 21 CFR Part 11, cGMP, GAMP5, and Annex 11.

Experience

1. Senior Analyst

   Deloitte

   Jul 2022 — Present · Delhi, IN

   Reviewing test scripts, test executions and test defects (both paper-based validation testing and validation testing using HP ALM and JIRA tool).Approve change controls (Including Scripts, URS, Sprint Backlog, Risk Assessment, UAT Protocols, Defect and Reports).Knowledge of the CSV methodologies, concepts of compliance, SDLC and risk based approach to CSV.Hands on experience in authoring and reviewing validation plan and validation summary report.Experience of delivering projects in waterfall as well as Agile software development framework.Experienced in tools: HP ALM for testing and JIRA for managing epics, features, user stories and dashboards.Experience in change management, which involved reviewing of Change Requests and Change Orders.Responsible for Project/Platform validation strategy.

Education

• North Maharashtra University

  Bachelor of Engineering - BE, Computer Science

  2013 — 2017