Quality Assurance Engineer for Automated Systems
vor 1 Woche
We are looking for a skilled Quality Assurance Engineer to join our team at Axepta SA. As a Quality Assurance Engineer, you will be responsible for ensuring compliance with regulations and standards related to automated and computerized systems in a biopharmaceutical manufacturing environment.
Key Responsibilities:
- Act as the main point of contact for quality compliance key topics regarding Automated and Computerized systems.
- Review and approve URS and relevant design documentation.
- Support risk assessment exercises and ensure compliance with cGMP and applicable regulations.
- Review and approve Computerized and Automated (SISA) systems related documentation.
Requirements:
- Minimum 5 years in a quality assurance engineering role in a biopharmaceutical manufacturing environment/medical devices.
- Experience in computerized and automated systems (MES, PLC SCADA systems, EMS, LIMS, ERP systems).
- Experience in health authorities inspections and proficiency in English and French.
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