VSI Expert – France

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

As part of a project for one of our client specialising in medical devices, we are looking for a VSI / VSA expert to support its teams on a pharmaceutical or biotech site, in compliance with regulatory requirements and best practice.

  • Support in the management of qualification/validation activities for critical systems.
  • Coordinating with project teams and internal/external stakeholders.
  • Ensuring compliance with FDA regulations and GAMP 5 best practice throughout the validation phases.

 

 

Skills required :

  • Proven experience (minimum 5 years) in qualification and validation of computerised systems (VSI / VSA) in the pharmaceutical or biotech sector.
  • In-depth knowledge of FDA requirements.
  • Knowledge and application of GAMP 5.
  • Significant experience in the qualification of monitoring systems (environment, critical equipment, etc.).
    People skills :
  • Ability to adapt to demanding and regulated environments.
  • Agile mindset, with a proactive and solution-oriented approach.
  • Good communication skills to work cross-functionally and collaborate with multidisciplinary teams.

Summary

Contact

Apply for this job

Similar career opportunities