As part of the development of its activities, our client, a rapidly growing biopharmaceutical company based in the canton of Vaud, is looking for a QA Systems Specialist to join its Quality Assurance team at a growing biotechnological production site.As a member of the Quality Assurance team, you will contribute to the maintenance and improvement of the site's quality systems in accordance with Swiss, European, and international GMP/cGMP requirements and will intervene in various quality processes related in particular to document management, electronic quality systems (eDMS/eQMS), GMP, CAPA, and change controls. This position offers strong transversality with the Production, QC, Engineering, and Global Quality teams.RESPONSIBILITIESQuality Systems & Compliance- Act as a SME for eDMS and eQMS systems.- Provide support for processes related to document management, CAPA, and change controls.- Manage document control processes and GMP controlled copies.- Participate in the physical and electronic archiving of quality documents.- Maintain training matrices and ensure training in quality systems.- Participate in the update and continuous improvement of quality processes & procedures.- Support teams on quality systems and GMP documentation practices.- Support teams in the daily management of quality systems.- Participate in the onboarding and training path of new employees.- Continuous Improvement.- Participate in monitoring quality KPIs and creating dashboards.- Contribute to quality investigations, CAPA, and change controls.- Participate in internal audits as well as the preparation of regulatory inspections.- Ensure a high level of compliance and permanent inspection readiness of the site.REQUIRED PROFILE- Bachelor or Master in a scientific field (pharmacy, chemistry, biology, biotechnology, or equivalent).- Minimum 2 years of experience in a GMP biotechnological environment.- Experience with electronic quality systems (eDMS/eQMS).- Good understanding of GMP requirements and quality processes.- Experience with Veeva is an asset.- Fluent French and English.- Team spirit, rigor, and solution-oriented.- Ability to evolve in a dynamic and demanding environment. jid20f24a7aen jit0520aen jpiy26aen