Senior) Manager Quality Operations Analytics
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- Support GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers
- Support Tech Transfer of Analytical Method and provide Quality Oversight for GMP compliant execution
- Provide quality support to programs ensuring smooth transition from development to commercial
- Manage Events (OOS/OOT/OOE), Changes (QC), related CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers
- Lead continuous improvement of quality processes associated to commercial medicinal products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls
- Collect Key Quality/Compliance Indicators for periodic review of local Quality Management System
- Monitor Quality Systems for trends and notify management of events requiring and immediate action Our expectations:
- A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
- Minimum 4 years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
- Strong background in analytical sciences for biologics
- Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP & GDP requirements for Pharmaceuticals and Combination Products, including Biologic Products
- Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
- Experience with regulatory agencies such as the FDA, EMA, etc
- Proven success in third-parties’ quality management
- Excellent communication skills in English, both written and oral, French as an asset
- Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm
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 € 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
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