Senior Validation Specialist

il y a 4 jours

Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein
About the Role

Just Evotec Biologics EU is seeking a highly motivated Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our computerized systems.

Key Responsibilities
  • Ensure the application of Good Manufacturing Practices (GMP) to GxP computerized systems, including laboratory information management systems, laboratory tools, enterprise resource planning systems, data historian solutions, manufacturing execution systems, and quality management systems.
  • Act as the Quality Assurance contact for GxP systems, attending meetings and working closely with the CSV team to move subjects forward.
  • Review and approve qualification and validation documentation, ensuring compliance 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.
  • Excellent analytical, organizational, and summarizing skills, with the ability to work independently and adapt to changing priorities.
  • Fluency in both written and spoken French, with a strong level of English (both writing and speaking) to communicate with our partners.
  • Familiarity with Good Manufacturing Practices, particularly annexes 11 and 15, and GAMP5.
  • Knowledge of one or more of the listed systems as a user.
What We Offer

As a Quality Assurance Specialist at Just Evotec Biologics EU, you will have the opportunity to work in a dynamic and innovative environment, contributing to the development of our biomanufacturing site. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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