Axepta SA QA CSV Engineer-Pharma Envoyer

For our client, leader in the biopharmaceutical field, is currently looking for a QA Validation Engineer - CSV - Permanent position

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

For more information : adrien.menard@axepta.com