Fresenius Kabi Austria, with headquarters in Graz and further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region. Shortfacts Einsatzort: Graz Ausmaß: Full-time Eintrittsdatum: ab sofort Anstellungsverhältnis: unlimited We are caring for our employees Reliable employer Strong global growth International career opportunities Comprehensive education and training Homeoffice Jobticket Active health promotion Free parking space Bikeleasing Canteen Joint company events Ihre Ansprechpartnerin Your contact person Fresenius Kabi Austria Mag. Celina Gößler, MA Hafnerstraße 36 8055 Graz karriere-fresenius-kabi.at Qualified Person Biopharmaceuticals (m/f/d) Your tasks Exercising the role of a qualified person in terms of the required product quality and the economic efficiency of the company Ensuring the quality of biopharmaceuticals in accordance with AMG/GMP/cGMP and other external and internal pharmaceutical guidelines Representation of the area of responsibility in audits and inspections Approval of quality assurance and quality control documents Management and coordination of cross-location investigations Collaboration in the implementation of new products and projects Conducting internal and external audits Creation, maintenance and training of biopharmaceutical-related work regulations and design of organisational processes Assessment of changes, deviations and complaints Our expectations Completed scientific or technical education (university, technical college) Compliance with the requirements of AMBO 2009 for practising as a qualified person Experience in the manufacture or testing of aseptic and sterile medicinal products is an advantage Several years (at least 5 years) of professional and management experience in production/QC/QA in an international pharmaceutical company Comprehensive knowledge of (c)GMP, AMBO, regulatory requirements and relevant country-specific regulations Strong management skills and a high degree of personal responsibility Highly process- and quality-oriented, assertive and structured approach to work Communication skills, negotiating skills, personal responsibility and decision-making skills Social skills, resilience, flexibility Good application-oriented IT skills (databases, MS Office) Excellent written and spoken German and English skills We offer Highly varied range of tasks Training opportunities and personal development within the company Career opportunities in an international pharmaceutical company Attractive, performance-based remuneration (minimum gross annual salary of € 75,000; higher salary depending on qualifications) We are caring for our employees Reliable employer Strong global growth International career opportunities Comprehensive education and training Homeoffice Jobticket Active health promotion Free parking space Bikeleasing Canteen Joint company events