beBee background
Professionals
>
Radnor
premium
Irina Smilansky

Irina Smilansky

Senior CSV Engineer/Auditor in Pharma Industry

Pharmaceutical / Bio-tech

Radnor, Township of Radnor, Delaware

Social

Social Networks

Services offered

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.

Computer system validation
Auditing
Quality assurance
Regulatory compliance
Risk assessment
Approximate rate: USD$ 75 per hour

Experience

  • 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

Education

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 

Professionals in the same Pharmaceutical / Bio-tech sector as Irina Smilansky

Professionals from different sectors near Radnor, Township of Radnor, Delaware

Other users who are called Irina

Jobs near Radnor, Township of Radnor, Delaware

  • Work in company

    CSV Engineer III

    PM Group

    Overview · The CSV Engineer III position is an exciting opportunity to join PM Group's quickly growing Philadelphia-area Outsourced Technical Services (OTS) team. Outsourced Technical Services (OTS) is an integral part of PM Group's ability to support clients across the complete ...

    Conshohocken

    13 hours ago

  • Work in company

    Supplier Qualification Lead

    Hikma Pharmaceuticals

    We are seeking a talented Supplier Qualification Lead to join our team. · End-to-end supplier qualification. · ...

    Cherry Hill

    3 weeks ago

  • Work in company

    Director of Strategic Partnerships – Partner

    Maven Executive Solutions

    This is a newly created role for a commercially driven channel leader to build and scale ValGenesis' strategic partner ecosystem across the Northeast U.S. · ...

    Philadelphia

    3 weeks ago