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
We are looking for a Manager Compliance and Instrumentation to our QC team
Are you a QC enthusiast and ready to take the next career step? Then we have the perfect opportunity for you: Join us as Manager of Compliance and Instrumentation in our production unit in Halden, Norway within the QC (Quality Control) team.
The main activities of the department are instrument qualifications and computer systems. The role will be responsible for ensuring and taking responsibility for the implementation and compliance status of the instruments and equipment used in the quality control department, generation of annual quality reports and deviation handling.
- System owner for QC computerized systems and equipment and hereunder responsible for the acquirement, qualification and validation of new systems and equipment.
- Maintain overview of the instruments and equipment used in the department and responsible for managing replacement plan for aging instruments and equipment.
- Responsible for handling and investigation of QC deviations according to applicable procedures and timelines.
- Responsible for equipment calibrations, maintenance, and/or repair.
- Ensure that the system and equipment’s are in a validated state.
- Maintenance and management of QC systems to ensure quality control and documentation procedure in accordance with GMP (Good Manufacturing Practices), ISO and ICH, within our own responsibility area.
- Communicate within own expertise/field to external Government and participate in audits or other questions regarding compliance and activities within own responsibility area.
- Use the change control, event handling and CAPA/ action management processes in compliance with the global QM.
- Automate and optimize processes.
- Implement and adhere to all relevant QM documents.
- Contribute to complaint investigation related to quality defects within area of responsibility.
- Perform trend evaluations for test method performance, equipment, and critical quality attributes (CQA).
- Management and leadership, professional responsibility of the QC Compliance and Instrumentation department.
- Education from university in microbiology/ chemistry/ biotech/ Pharmacy equivalent to MSc
- A minimum of 5 years’ experience from equivalent position
- In-depth knowledge and experience in Quality Control
- Profound knowledge in Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5
- Experience in Quality Management System, Data Management and Data Integrity
- Collaboration and capacity to work cross functional/ sites/ cultures
- Drive change, transparent and communicate clearly
- Fluency in Norwegian and English
If you are interested in this position, feel free to apply for this position!
Please apply before the 31st of May 2022.
For more information about the position, please contact: QC Director:
Applicants will be considered on an ongoing basis.