Quality Assurance Engineer

vor 4 Wochen


Orbe, Waadt, Schweiz AXEPTA SA Vollzeit
Job Title: QA Validation Engineer - CSV

We are seeking a highly skilled QA Validation Engineer - CSV to join our team at AXEPTA SA. As a key member of our quality assurance team, you will be responsible for ensuring the compliance of our automated and computerized systems with regulatory requirements.

Key Responsibilities:
  • Act as the primary point of contact for quality compliance matters related to automated and computerized systems.
  • Review and approve URS and relevant design documentation to ensure compliance with cGMP and applicable regulations.
  • Support risk assessment exercises and review computerized and automated systems-related documentation to ensure compliance.
  • Collaborate with process engineering and automation teams to ensure qualification and validation of all systems.
  • Create SOPs for automated and computerized systems qualification/validation, including 21CFR part 11 and data integrity requirements.
  • Perform quality audits for computerized and automated systems suppliers as needed.
Requirements:
  • Minimum 5 years of experience in a quality assurance engineering role in a biopharmaceutical manufacturing environment or medical devices.
  • Experience in computerized and automated systems (MES, PLC SCADA systems, EMS, LIMS, ERP systems).
  • Experience in health authorities inspections.
  • Proficiency in English and French.

We offer a dynamic and challenging work environment, and we are committed to supporting the growth and development of our employees. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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