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Qualified person biopharmaceuticals (m/f/d)

Graz
Fresenius Kabi Gruppe
€ 80.000 pro Jahr
Inserat online seit: 1 April
Beschreibung

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

Fresenius Kabi Austria

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz

#J-18808-Ljbffr

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