Quality Assurance Engineer for Automated Systems

vor 1 Woche


Orbe, Waadt, Schweiz Axepta SA Vollzeit

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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