Compliance Consultant / Computer System Validation

Compliance Services - Slowakei - Kosice

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About Arcondis

Wir schaffen Mehrwert durch funktionsübergreifende, ausgefeilte Projektabwicklung und intelligente Implementierung.


Unsere Kunden lieben die Zusammenarbeit mit uns aufgrund unserer einzigartigen Fähigkeiten, unseres pragmatischen Ansatzes und unseres unbedingten Erfolgswillens. We make healthcare better.

Open Position
Mission

Tasks and responsibilities

  • Advice clients as a project manager or project employee in the conception and implementation of software validation projects, hardware qualification projects and IT compliance projects in a regulated environment
  • Development, production and logistics for the pharmaceutical and medical technology industry
  • Implementation of IT compliance audits in the client environment
  • Client advice on the conception and implementation of new IT compliance requirements from the regulated environment as well as the conception and implementation of IT quality management systems
  • Conception and implementation of IT quality management systems
  • Training & coaching in the field of computer system validation (CSV), hardware qualification and IT compliance
  • Support in the acquisition of new clients and projects
Studies

Your profile

  • Academic background in the field of business informatics, engineering, pharmaceuticals or a comparable subject
  • Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
  • Very good knowledge of the underlying regulatory requirements (FDA, EU, GxP, ISO 13485) and best practices (GAMP5)
  • At least 3 years of professional experience in the field of computer system validation and / or qualification of hardware as well as in IT compliance topics
  • Experience in setting up IT quality management systems in the pharmaceutical and / or medical technology field
  • SAP R3 / SAP Hana experience is an advantage
  • Fluent written and spoken English
  • German language proficiency a plus
  • Willing to travel
    -Enthusiastic and client focused
Contact

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