Quality Expert Medical Device (m/f)

      Novartis

      Schaftenau - vor 1 Monat

      Come join us and become a part of our world. Together we can discover new ways to improve and extend people's lives. As part of the global Novartis Group our sites in Kundl and Schaftenau are specialized in development and production of antibiotics and biologics.

      Quality Expert Medical Device (m/f)

      Global Drug Development / Schaftenau

      Area of Responsibility

      • Ensure technical development and manufacturing operations of assigned Medical Devices/ Combination Products are conducted in accordance with Novartis Quality System requirements
      • Ensure QA aspect in diverse projects (e.g. development of new tools, processes) and provide functional expertise
      • Write, review and approve deliverables (e.g. procedures, clinical trial material, components) and related tools (e.g. IT, document systems, training tools) to ensure GMP compliance
      • Accountable for monitoring, analysis and reporting of GMP related KPIs
      • Maintain sound working relationship with internal customers and external partners
      • Release of medical devices for clinical studies and commercial use
      • Support Medical Device Risk Assessments
      • Represent Medical Device Quality in initiatives and cross-divisional projects
      • Perform or support inspections and audits as required

      Qualifications

      Education: Academic degree in Chemistry, Pharmacy, Microbiology or Biotechnology or similar
      Languages: Fluent level of English, German/French beneficial
      Experience: At least 3 years of related experience with medical devices/combination product manufacturing, thorough understanding of device development and life-cycle management, and knowledge of related regulations, guidelines and GMP compliance
      Personal Skills: Strong project management skills, strong communication and presentation skills, and team spirit

      Please apply online under the following link Online Application (Job ID 243592BR)
      Contact: Cornelia Walch, Senior Staffing Manager

      We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 51.216,06 per year).

      Sandoz GmbH
      Biochemiestrasse 10
      6250 Kundl, Austria
      Tel. 05338/200-0
      www.novartis.at