Compliance Consultant / Computer System Validation

Compliance Services - Slovakia - Kosice

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About Arcondis

ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,


information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

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 training 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
  • SAP R3 / SAP Hana experience is an advantage
  • 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
  • Fluent written and spoken German and English
  • Traveling
  • Enjoyment of client service
Contact

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