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Il y a 2 mois
Just-Evotec Biologics EU is seeking a highly motivated Quality Assurance Specialist with expertise in Computerized System Validation (CSV) to join our growing team.
As part of our ongoing bioproduction site development, you will play a crucial role in ensuring compliance with Good Manufacturing Practices (GMP) for all GxP computerized systems. Your responsibilities will encompass:
- Acting as the primary point of contact for Quality Assurance regarding GxP systems under your purview, actively participating in meetings and collaborating closely with the CSV team.
- Serving as a technical liaison between operations and the review and approval of qualification and validation documentation, adhering to GMP regulations.
- Providing quality oversight during protocol execution and offering support to address any discrepancies that may arise.
The GxP systems you will manage, depending on your expertise, include:
- Laboratory Information Management System (LIMS)
- Laboratory Tool: Empower
- Enterprise Resource Planning (ERP): SAP
- Data Historian Solution: PI and Kepware
- Manufacturing Execution System (MES): PAS-X
- Quality Management System (QMS): Veeva
Your Profile:
- 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 team spirit, and a genuine curiosity for learning.
- Excellent analytical, organizational, and synthesizing abilities, coupled with adaptability and the ability to work independently.
- Familiarity with GMP, Annexes 11 and 15, and GAMP5.
- Knowledge of the qualification/validation process is highly advantageous.
- Fluency in written and spoken French, as well as a good level of English for effective communication with partners.
