Responsibilities
* 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
Qualifications
* 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
Benefits
* 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)
Company
Fresenius Kabi Austria
#J-18808-Ljbffr