Fresenius Kabi Norge AS is a leader in Norway in its segment producing medicines, with revenues to numerous countries worldwide. The position is located in our growing production facility in Halden with over 660 employees. Fresenius Kabi is included in the German group Fresenius SE, with headquarters in Frankfurt. The group has currently more than 274 000 employees.
QA Manager Quality Management Systems
We are looking for a QA Manager who will be responsible for all the quality management systems at Fresenius Kabi Norway, Halden in close interactions with the corporate organization. The position is part of the management group in the Quality Assurance area and reports to the Quality Assurance Director. We are looking for positive and proactively colleague which will work with our team to develop the Quality Assurance organization and to improve our systems and processes to meet the future requirements
The position has the overall responsibility for the systems and processes related to; Documents, Pre-printed materials, Deviation and Action, Change Control, Master Batch Record, Management Review, Audit trail, quality related training and quality performance indicators.
- Responsible for management, development and oversight of the QMS team.
- Proactively ensure compliance towards ISO 9001, 1348, cGMP regulations and national regulations for the quality management systems, and actively maintain and develop the systems in responsibility.
- Overall responsible for effective and streamlined processes within the department to meet targets for defined KPIs.
- Qualify as Lead auditor for internal and external audits
- Participate and host, if needed, external audits/inspection at the site
- Support the site organization with training in the respective quality systems
- External presentation and communication towards customers, authorities and corporate organization in topics related to quality assurance and quality management systems.
Requirements to education, experience and personal characteristics
- Master degree in Chemistry, Biology or Pharmacy
- 3-5 years’ experience in a Management position with personnel and budget responsibilities, and documented 3-5 years’ experience in ISO/cGMP quality systems
- Excellent ability and high interest in using, managing and developing IT-systems for Quality Assurance.
- Excellent skills in writing and speaking Norwegian and English.
- Experience from an international company with cooperation and communicating in different levels in the organization.
- Personnel skills: Positive and proactive mind-set, good communication and cooperation skills, quality and target oriented and able to take decisions.
If you would like more information about the position, please contact QA Director Anne-Mette Horsrud Akre, tel: +47 69 21 11 00.
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