Quality Assurance Engineer
vor 4 Wochen
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.
- 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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