Fresenius Kabi Austria, with headquarters in Graz and a 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
Vollzeit

Eintrittsdatum
ab sofort

Anstellungsverhältnis
unbefristet

We are caring for our employees

• verlässlicher Arbeitgeber
• starkes globales Wachstum
• internationale Karrieremöglichkeiten
• umfassende Aus- und Weiterbildung
• aktive Gesundheitsförderung
• Gratis Parkplatz
• Kantine
• gemeinsame Firmenevents

Ihre Ansprechpartnerin:

Fresenius Kabi Austria GmbH
Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz

Qualified Person Biopharmaceuticals (m/w/d)

Ihr Aufgabengebiet

• 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

Wir erwarten

• 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

Wir bieten

• 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 EUR 75,000; higher salary depending on qualifications)

JETZT BEWERBEN