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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.

Tasks:

  • 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

 

Requirements:

  • 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