Nitheesh Naidu Bodipati

Recently graduated with foundational knowledge in Computer System Validation (CSV) and pharmaceutical compliance. Familiar with the complete CSV lifecycle: URS, FS/FRS, Risk Assessment, Validation Plan, IQ/OQ/PQ, and VSR. Understanding of GAMP 5 guidelines, 21 CFR Part 11, and FDA audit preparedness. Skilled in drafting validation documents, test cases, and traceability matrices. Hands-on experience through a capstone project and an internship in regulated environments. Proficient in MS Office and basic SQL queries. Strong analytical skills, high attention to detail, and a compliance-driven mindset. Effective communicator and team player with a quick learning ability.

• Familiar with the complete CSV lifecycle: URS, FS/FRS, Risk Assessment, Validation Plan, IQ/OQ/PQ, and VSR.
• Understanding of 21 CFR Part 11, GAMP 5 guidelines, and FDA audit readiness.
• Proficient in creating and maintaining Traceability Matrix and risk-based testing documentation.
• Exposure to software validation in pharmaceutical and clinical environments.
• Clinical System Validation Simulation, Drafted mock URS and functional specs for a clinical trial data management tool., Conducted a simplified RA and created an IQ protocol for a hypothetical EMR system., Created validation test cases and compiled a final VSR.