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Computer System Validation Consultant

Vissza a kereséshez

Computer System Validation Consultant

Computer System Validation Consultant


About our Partner

Our partner is a service provider company, leader in the Pharmaceutical and Medical Device sectors and we are looking for a new Computer System Validation Consultant in Budapest. With more than 1000 employees and 26 subsidiaries all over the world (Europe, Asia and the Americas), joining to their team means joining a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.


  • Ensure completeness and consistency of validation life cycle documentation for computerized systems used to control/monitor and manage data in laboratory and production environments
  • Resolution of fundamental Computer System Validation (CSV) compliance issues derived from the impossible implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
  • Ensure all project-related risks are well managed and deliverables are validated (for GxP)/tested (for nonGxP) in accordance to SOP and the associated CSV requirements
  • Ensure the project team complies with the methodology and SOP and uses the correct tools
  • Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
  • Prepare project and lifecycle reports and review/approve all other documents to ensure compliance with SOP
  • Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved in accordance with the prescribed SOP



  • 2+ years of experience with Computer System Validation
  • English language proficiency
  • Full availability to travel (up to 70%)
  • Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
  • Supervision of protocols execution activities
  • Excellent communication skills