Irina Smilansky

Highly accomplished and results-driven professional with expertise in computer system validation, regulatory compliance (FDA 21 CFR Part 11, GxP), and quality assurance. Skilled in leading audits, risk assessments, and implementing compliance strategies within complex environments.

• Senior CSV Engineer/CSV Auditor at Clinical Systems World, Radnor, PA | Nov 2018 – Present
• Senior IT System Solution Architect at GlaxoSmithKline | June 2018 – Nov 2018
• Senior Solution Architect at Clinical Systems, Radnor, PA | Feb 2014 – May 2018
• Senior Solution Architect at AstraZeneca, Wilmington, DE | Jul 2013 – Jan 2014
• Senior IT Analyst at American Board of Internal Medicine, Philadelphia, PA | Jan 2013 – Jul 2013
• Senior Database Developer at Accenture/Pfizer, PA | Aug 2011 – Jan 2013

Bachelor of Science (B.S.) in Computer Science and Applied Statistics

Taras Shevchenko National University of Kyiv — Kyiv, Ukraine

Professional certifications and training related to CSV, GxP, FDA compliance, and IT systems