Freelancer Computer System Validation & Software Development

Freelancer Compliance Services - Frankfurt, Basel

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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

Tasks and responsibilities

By joining the Arcondis Freelancer Pool, you will never have to chase opportunities actively. Whenever there is a suitable new project, we will contact you!

All about CSV:

  • Support our customers as a project manager for the design and implementation of software validation projects and IT compliance projects in regulated environments

  • Training & coaching in computer system validation (CSV), software development, hardware qualification and IT compliance

  • Implementation of IT compliance audits

  • Design and implementation of new IT compliance requirements in the regulated environment

  • Implementation of IT quality management systems


Your profile

  • Bachelor’s or Master’s degree in life sciences, computer science, engineering, pharmaceutics or in a comparable field

  • Several years of professional experience in computer system validation, qualification of hardware as well as in IT compliance topics

  • Experience in software development ("embedded software" and/or "app development")

  • Ideally professional experience in the pharmaceutical, medical device or other life science industries

  • Knowledge of Software as a Medical Device

  • Very good knowledge of dealing with regulatory requirements (FDA, EU, GxP, ISO 13485) and best practices (GAMP5)

  • SAP R3 / SAP Hana experience is an advantage

  • Experience in setting up IT quality management systems in the pharmaceutical or medical device environment

  • Very good written and spoken German and English skills

  • Willingness to travel


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