Quality Assurance Expert

il y a 3 semaines


Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein

Quality Assurance Expert - Computerized Systems Validation

We are looking for a dedicated Quality Assurance Expert with a focus on Computerized Systems Validation (F/M/D) to join our team at Just-Evotec Biologics.

In this role, you will play a crucial part in our bioproduction site development project, ensuring adherence to Good Manufacturing Practices for GxP computerized systems. Your key responsibilities will include:

  • Serving as the primary Quality Assurance representative for the GxP systems under your oversight, actively engaging in discussions and collaborating closely with the CSV team.
  • Functioning as a technical operations liaison for the evaluation and endorsement of qualification and validation documentation, ensuring compliance with GMP standards.
  • Providing quality oversight during the execution of protocols and assisting in the resolution of any discrepancies that may arise.

The GxP systems you will oversee, based on your expertise, may include:

  • Laboratory Information Management System: LIMS
  • Laboratory tool: Empower
  • Enterprise Resource Planning: SAP
  • Data historian solution: PI and Kepware
  • Manufacturing Execution System: PAS-X
  • Quality Management System: Veeva

Qualifications:

  • A Master's degree or equivalent, with 2 to 3 years of experience in validation/qualification and computerized systems.
  • Strong interpersonal and communication skills, a collaborative spirit, and a keen sense of curiosity.
  • Exceptional analytical, organizational, and synthesis skills, coupled with adaptability and independence.
  • Familiarity with GMP, annexes 11 and 15, and GAMP5 is essential.
  • Knowledge of the qualification/validation process is a plus.
  • Proficiency in written and spoken French, along with a good command of English for effective communication with stakeholders.

About Just-Evotec Biologics:

Just-Evotec Biologics is a premier biotechnology firm committed to advancing innovative biologics for a healthier future. Our mission is to develop state-of-the-art solutions in biomanufacturing to tackle global healthcare challenges.



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