Quality Assurance Specialist Computerized System Validation

il y a 3 semaines


Toulouse, Occitanie, France Evote Temps plein
Job Title: Quality Assurance Specialist Computerized System Validation

We are seeking a highly motivated Quality Assurance Specialist to join our team at Evotec. As a Quality Assurance Specialist, you will be responsible for ensuring that Good Manufacturing Practices are applied to the GxP computerized systems.

Key Responsibilities:
  • Be the Quality Assurance contact for GxP systems you are in charge: attend meetings, closely work with CSV team to move subjects forward.
  • Act as the technical operations relay for the review and approval of qualification and validation documentation, in an environment that complies with GMP Parts I and II as well as annexes 11 and 15.
  • Ensure quality oversight during protocol execution and support to handle discrepancies.
Requirements:
  • Master degree or equivalent, and at least 2 or 3 years of experience in qualification/validation and computerized systems.
  • You are recognized for your interpersonal and listening skills, for your team spirit and your curiousness.
  • You have excellent analytical, organizational, and summarizing skills. You are adaptable and autonomous.
  • You know one or more of the uplisted systems as a user.
  • You are familiar with Good Manufacturing Practices, particularly annexes 11 and 15, and you will also be familiar with GAMP5.
  • Being familiar with the qualification/validation process is an asset.
  • You are fluent in both written and spoken French.
  • You have a strong level in English (both writing and speaking) to be able to communicate with our partners.


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