CSV Engineer - Suisse Vaud Orbe - Axepta SA
For our client, leader in its field, is currently looking for a QA Validation Engineer - CSV.
YOUR 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
PROFILE :
• 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
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