QA CSV Engineer III (Global Site CSV/CSA SME Lead), Tolmar Pharmaceuticals
Hemadri is a well-versed professional, in the field of Validation, Technical Writing and Quality Assurance within the Pharmaceutical/Medical Device Industry/life sciences. He is currently entertaining as a QA Computer system Validation Engineer III at Tolmar Inc. In this role he is responsible for defining the strategy and reviewing the computer system validation deliverable’s for the Lab systems, Computerized systems, and Process Automation Systems and reviewing the Admin SOPS, User SOPS, reviewing specifications and assessing data integrity and 21 CFR 11.
Throughout his profession, he has gained great practice with writing operational and performance qualification test scripts, summarizing the validation activities and developing protocols/documents during the entire life cycle of Computer Systems Validation process including: User Requirements Specifications (URS), Functional Requirements Specifications (FRS), System Design Specifications (DS) and Vendor Assessment (VA). In addition, he is well versed in lettering/revising Standard Operating Procedures (SOPs), Work Instructions (WIs), Requirement Traceability Matrix (RTM) and Validation Summary Reports (VSR) via IQ, OQ and PQ for various pharmaceutical companies while staying in compliance with cGMP, GAMP, cGLP, and cGCPs. Experienced Computer System/Equipment Validation Engineer with a demonstrated history of working in various computerized systems of the pharmaceuticals industry. Skilled in Software Development Life Cycle (SDLC), validation life cycle, Testing, Microsoft Office, and Test Automation. Strong information technology professional with a Master’s Degree focused in Electrical and computer Engineering from University of South Alabama.