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Qualified Person Biopharmaceuticals (m/f/d)

Fresenius Kabi Austria GmbH -
Graz, ST

Jetzt bewerben

Details zur Stelle

Vollzeit

Vollständige Stellenbeschreibung

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

Jetzt bewerben

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