Vineeth Kumar Email & Phone Number

With over 5 years of professional experience in the Pharmaceutical, Healthcare, and Medical Device Industry, I have served as a Compliance Engineer Consultant, Validation Engineer, and Equipment Validation Analyst/ QA/ Technical Writer. My proficiency lies in authoring and executing comprehensive system qualification documentation, encompassing Validation/Test plans, user and Functional Requirements Specification, Test cases/scripts, Requirements Traceability Matrix (RTM) for IQ/OQ/PQ protocols, and summary reports. I bring extensive expertise in reviewing Standard Operating Procedures (SOP), Validation Master Plan (VMP), and Validation Summary Reports (VSP). Adept at navigating FDA regulations such as 21 CFR Parts 11, 50, 56, 58, 210, 211, 312, 314, and 820, as well as ICH – GCP Guidelines and ISO 13485, I also possess hands-on experience with analytical laboratory procedures and equipment, including HPLC, GC, UV-VIS Spectrometers, Spectrophotometer, Autoclaves, pH meters, and incubators. My knowledge extends to automated process control systems, clean room requirements, and Aseptic Environment protocols. Additionally, I have contributed to computer system validation, working with Laboratory Information Management System (LIMS) and Scientific Data Management System (SDMS). My experience includes handling CTUs like Autoclave, Cold storage, Ovens, and Incubator, and I am well-versed in Adverse Event Reporting System (AERS) and Electronic Document Management System (EDMS). Adept in Corrective Action Preventive Action (CAPA) analysis, I bring a comprehensive skill set to ensure project success.

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  Osmania University, Hyderabad

  Mechanical Engineering