QA Validation 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 automated and computerized systems with cGMP and applicable regulations.
Key Responsibilities:- Act as the main point of contact for all quality compliance key topics regarding Automated and Computerized systems (MES, EBR, PLC/SCADA, EMS, LIMS, ERP systems)
- Review and approve the URS and relevant design documentation
- Support actively the risk assessment exercises
- Review and approve Computerized and Automated (SISA) systems related documentation (procedures, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations
- Support the Commissioning & Qualification activities
- 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 if needed
- Ensure qualification and validation of all systems in close collaboration with process engineering & automation teams
- Must speak English and French
- Must have minimum of 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
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 QA Validation Engineer - CSV looking for a new challenge, please submit your application.
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