Quality Assurance Professional
il y a 4 semaines
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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