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QA Engineer with 2+ years in Computer System Validation & GxP Compliance
Validation Analyst with 2.6 years of hands-on experience in Computer System Validation (CSV) for GxP-regulated systems. Proven ability to lead end-to-end validation activities, including authoring key documents (GxP Assessment, VP, IQ/OQ, RTMs and VSR) and performing 21 CFR Part 11/ERES assessments. Skilled in GAMP 5, SDLC, and GDP & Cloud GxP Validation Concepts with a track record of ensuring system traceability and seamless cross-functional collaboration in pharmaceutical and biotech environments.
RGUKT RK Valley
B.Tech · Mechanical Engineering
August 1, 2019 – June 30, 2023
Mbipc, RGUKT RK Valley
Pre-University Course (PUC)
June 1, 2017 – May 31, 2019
AP Model School, Khajipet
SSC
June 1, 2017 – May 31, 2017
Consip Group of companies
CSV Validation Analyst
October 1, 2025 – Present
India
Grayradiant Data Services Pvt Ltd
Validation Analyst
January 1, 2024 – October 1, 2025
India
Cultural Fit Analysis
The candidate's experience is highly specialized in CSV within pharmaceutical and biotech environments, which aligns well with roles requiring strict regulatory compliance. The project diversity is limited to validation activities, and the educational background in Mechanical Engineering is not directly aligned with software QA, though the professional experience bridges this gap. The breadth of skills is focused on GxP and FDA compliance rather than general software testing methodologies or tools beyond basic functional testing and Jira. This specialization might limit adaptability to broader QA roles outside of regulated industries.
Soft Skills & Operational Fit
The candidate demonstrates strong organizational skills through maintaining detailed documentation and inventory lists. Collaboration with cross-functional teams is a recurring theme, indicating good teamwork and communication. The experience in audit readiness and adherence to regulatory standards suggests a detail-oriented and responsible work attitude. The candidate's soft skills align well with the operational demands of a QA Engineer role, particularly in regulated environments.