Beschreibung

Bracco Suisse SA based in Geneva (Switzerland) is a company of the Bracco Group, a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries. At our manufacturing site based in Geneva (Switzerland) we are looking for a:QA SpecialistJob missionTo support Quality Assurance Geneva Manufacturing Site. The role involves ensuring activities are performed in compliance with current pharmaceutical GMP requirements (EU and US) as well as with the BRACCO Quality and HSE Management systems. Under the responsibility of the Quality Assurance Manager, you will have to perform:- Record review- Review production records- Release incoming consumables- Review packaging records- Improve, maintain and ensure a continuous improvement of the following local Quality Systems- Ensure the quality of the product:- Ensure activities related to the sterile production quality are conform to company policies and Quality directives.- Main contact in case of sterile production issues and manage deviations including those related to production, maintenance, packaging, and utility activities, by driving and in collaboration with the relevant functions.- Define, implement, and follow up on corrective and preventive actions (CAPA) within the scope of responsibility, ensuring timely execution and effectiveness in line with defined deadlines.- Manage complaints related to the review and approval of the access to sterile production area.- Ensure the review, and timely approval of QA documents.- Review/approve for issuance of GMP documents related to production area (SOPs, protocols, etc.).- Participate in and/or lead risk analyses, in collaboration with cross-functional teams.- Contribute to change control process.- Auditor in self-inspections and external audits (lead auditor if qualified).- Support external audit, notified Bodies and Authorities.- Audit trail review of GMP systems.- Training for classified areas.- Ensure any signal detection may have a potential impact on product quality.- Promptly report any Quality Alert or issue to the Quality Manager and the Quality Unit Manager and actively contribute to the resolution of significant quality issues.- Work effective and efficiently with Sterile Production, Maintenance, Packaging, and other relevant functions to support product quality throughout its lifecycle.Management- Indirect management of projects.Profile & Skills- University degree in Pharmacy, Chemistry or Biochemistry- Over 5 years in Quality Management in Pharmaceutical Industry- Solid knowledge of cGMP, including Annex 1- Experience in lyophilized products and aseptic process- Indirect Management in project or commitment, flexibility, and problem-solving working; cross functional behavior.- Fluency in French and English (both oral and written)- Excellent team spiritWe offer- The opportunity to join a well-established and successful company with bright prospects and manufacturing sites and production facilities- A development perspective and the opportunity to bring and utilize your know-how and expertise- Competitive packages as well as first class benefits complete this offerIf you recognize yourself in this profile and are looking for a new challenge, send us your complete application (cover letter & CV) through this link. jidce4d7a5aen jit0625aen jpiy26aen