The plant in Halden specializes in the production and distribution of IV Drugs and Standard solutions, both for Fresenius Kabi worldwide and through product partnering. In Norway, we currently have a factory in Halden and a marketing office in Oslo, and we have just over 550 employees. Fresenius Kabi Norge AS is part of the German group Fresenius SE, with headquarters in Frankfurt, Germany. The group currently has over 300,000 employees, in more than 100 different countries around the world. For more information - See our website: Fresenius-kabi.com/no
Quality Control Director (m/f/d)
Are you a Quality Management enthusiast and ready to take the next career step? Then we have the perfect opportunity for you: Join us as Quality Control Director in our production unit in Halden, Norway within the Pharmaceuticals & Devices Division.
- Responsible for the overall management of the QC department and leadership
- Facilitate secured and effective processes to release raw materials, primary packaging and finished products in accordance to Good Manufacturing Practice (GMP) as well as analytical method development / validation and QC Lab Data System
- Ensure that analytical validation, development and technology transfers are performed in accordance to GMP
- Maintain and develop relevant systems to ensure quality control and documentation procedure in accordance to GMP, ISO and ICH guidelines
- Responsible for approving contracts with external clients for the QC area
- Review and approve regulatory documents for formulation and testing
- Lead critical project initiatives at Fresenius Kabi Norge.
- Higher university degree in chemistry, biotechnology, microbiology, pharmacy or similar field
- Several years of experience in Quality Management within the sterile manufacturing industry
- Extensive knowledge of the pharmaceutical industry, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Quality Management Systems
- In-depth knowledge and experience in Quality Control, Technology Transfer, Pharmaceutical Product / Process Development, Production, Business Development and Contract Negotiations
- Experience in Change Management
- Broad experience in leading teams
- Excellent command of the English language
- Knowledge of Scandinavian languages is a plus
If you are interested to go on this journey with us, feel free to apply for this position!
Please apply in English before the 5th of March 2021.
For further information, please contact Teresa Martin, Fresenius Kabi Deutschland GmbH. E-mail: Teresa.email@example.com