Your tasks
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Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
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Manage a GMP compliant transition of Programs from development to commercial
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Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product
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Manage GMP compliance during Analytical Transfer activities
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Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
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Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
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Manage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers
Our expectations
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A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
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Minimum seven years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
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Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
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Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
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Experience with regulatory agencies such as the FDA, EMA, etc.
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Proven success in third-parties’ quality management
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Excellent communication skills in English, both written and oral, French and German as an asset
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Demonstrated ability to work effectively in a team-oriented environment
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Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm
We offer
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Highly varied range of tasks
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Training opportunities and personal development within the company
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Career opportunities in an international pharmaceutical company
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Attractive, performance-based remuneration (minimum gross annual salary of € 60,000; higher salary depending on qualifications)
Benefits
- 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