Avadhesh B.
Computer System Validation, Quality and Data Integrity Professional
- Role
- Sr Csv Technology Analyst at Getinge
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Avadhesh B.
10+ years of experience in Information Systems Validation, functioned as Validation SME and Quality Representative/Reviewer in highly regulated Pharmaceutical companies. • Strong expertise in validating highly regulated enterprise systems like SAP, Oracle\'s E-Business Suite, Werum PAS|X MES, Axway Track and Trace, TrackWise, Windchill, and Salesforce. • Expertise in creating Validation Plans, Requirements Specifications, Master test plans, Traceability Matrices, Test Summary Reports, and Deviation/Incident Reports. • Experience in all phases of SDLC: Requirement gathering, Design, Development, Testing, Defect Management, Deployment, and Change Control management. • Expertise in creating documents related to Computer System Validation Lifecycle (CSV) such as - Validation Master Plan (VMP), Standard Operating Procedures (SOPs), Installation Qualification (IQs), Operational Qualification (OQs), Performance Qualification (PQs), and Validation Summary Report (VSR).• Thorough knowledge of 21 CFR Part 11 and a good understanding of cGMP, GLP, and GCP• Thorough understanding of the Validation Life Cycle (VLC) and Software Development Life Cycle (SDLC)• Proficient in Technical Writing with strong experience in developing Enterprise Lifecycle documentation required for application development projects like Project Plans, URS, FRS, FDS, RTM, Test Plans, Test Cases and Support Plans.
Experience
Sr Csv Technology Analyst
Jul 2019 — Present · Wayne, NJ, US
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Pharmacy
2006 — 2011
Northeastern University
Master of Science - MS, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2011 — 2013
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