Sai Anuhya Kamarajugadda
Dallas,Texas
Summary
Dynamic Computer System Validation Engineer with a proven track record , enhancing operational efficiency through expert management of validation protocols and CAPA. Skilled in FDA regulations and equipment calibration, adept at cross-functional teamwork and continuous learning. Achieved significant improvements in system compliance and data integrity, showcasing a blend of technical proficiency and collaborative prowess.
Overview
3
3
years of professional experience
Work History
Computer System Validation Engineer
Takeda Pharmaceuticals
Dallas, Texas
01.2021 - 07.2024
- Involved in end-to-end validation life cycle phases for various project requests and change requests for various ERP and R&D systems.
- Create and/or update various validation documents, such as the Validation Plan and Report, User Acceptance Test Plan, UAT Test Cases, Traceability Matrix, etc.
- Documented entire validation process and recorded all changes.
- Facilitate UAT and attend Project/Change Requests meetings with different stakeholders (IT, Business, Project Manager, etc.).
- Develop, review, and execute Validation Protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Prepare and maintain Validation Master Plans (VMPs), Validation Plans, Test Scripts, and Summary Reports.
- Made sure all the documentation and records met 21 CFR Part 11 requirements.
- Involved in the development of master data within the Laboratory Information Management System (LIMS).
- Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.). To ensure the approach and execution align with industry standards, as well as Biogen's expectations, through the review and approval of life cycle deliverables.
- Performed multiple COTS 3 and COTS 4 validations for laboratory and manufacturing equipment, including: Karl – Fischer Titrators, balances, Multi-Q Container Closure Integrity Tester, osmometers, roller compactor, Beckman Coulter MET ONE Particle Counter, Particle Measuring System, vacuum oven, HPLCs, microfluidizers, and imprinter.
- Responsible for assisting with the creation and testing of LIMS Master Data.
- Supported regulatory inspections and audits by presenting validation documentation, and addressing queries.
- Managed the validation lifecycle for upgrades, patches, and system decommissioning activities.
- Techniques/Software: Failure Modes and Effects Analysis (FMEA), Life Cycle Management, Process Validation, Risk Assessments, and Data Integrity Assessments.
- Handled all the normal and emergency change requests using ServiceNow.
- Communicated effectively with customers and contractors to facilitate business operations.
- Monitored compliance with established standards and procedures related to validation activities.
- Worked with cross-functional teams to achieve goals.
- Maintained updated knowledge through continuing education and advanced training.
Education
Bachelor of Technology - Information Technology
Jawaharlal Nehru Technological University
Hyderabad, Telangana, India.05-2016
Skills
- Record keeping
- Validation protocols
- Equipment calibration
- CAPA management
- FDA regulations
- Testing protocols
Timeline
Computer System Validation Engineer
Takeda Pharmaceuticals
01.2021 - 07.2024
Bachelor of Technology - Information Technology
Jawaharlal Nehru Technological University
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