Quality Assurance Professional

il y a 4 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 specializing in the validation of computerized systems 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 (GMP) for GxP computerized systems. Your key responsibilities will include:

  • Serving as the primary Quality Assurance representative for the GxP systems you oversee, actively engaging in meetings and collaborating closely with the Computerized System Validation (CSV) team.
  • Functioning as a liaison for technical operations, reviewing and approving qualification and validation documentation in line with GMP standards.
  • Providing quality oversight during the execution of protocols and assisting in resolving any discrepancies that may arise.

The GxP systems you will be responsible for managing may include:

  • Laboratory Information Management System (LIMS)
  • Laboratory tool: Empower
  • Enterprise Resource Planning (ERP): SAP
  • Data historian solutions: PI and Kepware
  • Manufacturing Execution System (MES): PAS-X
  • Quality Management System (QMS): Veeva

Qualifications:

  • A Master's degree or equivalent, with 2 to 3 years of experience in validation/qualification and computerized systems.
  • Strong interpersonal and listening skills, with a collaborative spirit and a keen sense of curiosity.
  • Exceptional analytical, organizational, and synthesis skills, along with the ability to adapt and work autonomously.
  • Familiarity with GMP regulations, including annexes 11 and 15, and GAMP5 guidelines.
  • Knowledge of the qualification and validation processes is advantageous.
  • Proficiency in written and spoken French, with a good command of English for effective communication with partners.

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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