Your tasks

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

Fresenius Kabi Austria

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz

(Senior) Manager Quality Operations Analytics (m/f/d)

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