Fresenius Kabi Norge AS

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

Ready to enter the industry as a QP Trainee?

The Qualified Person Trainee is an entry level position that works under the direction and supervision of the Halden Quality Assurance Manager – Product Release, supports the planning and execution of batch review and release activities.  They are responsible completing an intensive two-year training program and becoming a NOMA licensed Qualified Person. They will support a team of Qualified Persons which directly manage all batch review, approval, and release activities.  As their training progresses, they will take on more responsibility until they transition into a Qualified Person position.   They will participate and support projects and activities for the facility to improve product and process quality. 

They will analyze quality issues (such as events, deviations, complaints, lab out of specifications (OOS), etc) to identify the needed corrections and corrective actions.  The QP Trainee will also be a key resource in identifying and developing best practices for process improvement, problem solving, and driving customer satisfaction.

The support to Halden operations will include providing daily guidance on Good Manufacturing Practices (cGMPs) and effective risk management. This position is hands-on in a fast-paced environment which interacts with multiple functions (QC, Production, Purchasing, Engineering, Regulatory Affairs, etc.) and other internal sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.

Main responsibilities

  • Complete an intensive two-year training program learning production, quality control, and quality assurance activities within the facility
  • Support a team of qualified persons within the Halden plant helping them manager their workload by handling events and deviations
  • Manage failure investigations for events, deviations, and complaints to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances
  • Work with team members to ensure that corrective measures meet acceptable standards and that documentation is compliant with all regulatory requirements
  • Communicate with customers and resolving all customer inquiries
  • Support other event and deviation owner to ensure investigations are complete and documentation stands on its own during external review
  • Collaborates with internal groups to ensure quality standards are in place and improvements are implemented according to defined plans
  • Lean, understand, model, and champion current Good Manufacturing Practices behaviors within the facility
  • Provide support and input to the Q-KPI reporting tool for the site
  • Support and communicate with the site at the Quality Circle meetings
  • Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies
  • Take on additional responsibilities as defined by the site QA Director

Requirements:

  • Qualified individual should have a bachelor’s degree in Science in: Pharmacy, Chemistry, Biology, or Chemical Engineering. Advanced degree preferred
  • Solid leadership, facilitation, and communication skills
  • Understanding of problem solving or continuous improvement methodologies
  • Awareness of ISO Quality Management Systems
  • Excellent communication and interpersonal skills
  • Ability to work independently across multiple organizations
  • Good report writing and reviewing skills

Desired Qualifications:

  • Experience working in a Quality Control Laboratory
  • Experience in the pharmaceutical or medical device manufacturing facility
  • Good communications skills in Norwegian and English
  • Exposure to process and/or software validation methods
  • Operational Excellence/Six Sigma/Lean training or certifications
  • Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
  • Experience using Sparta Trackwise and/or SAP

Personal characteristics

  • Positive mind-set and an including attitude
  • Ability to build good relationships
  • Ability to work in a structured, systematic and dynamic environment
  • Good communication- and cooperation skills
  • Proactive and goal oriented
  • Organized and quality oriented
  • Ability to make decisions

If you are interested to go on this journey with us, feel free to apply for this position!

Please apply before the 25th of October 2021.

For more information about the position, please contact: Aaron.Snyder@fresenius-kabi.com. Applicants will be considered on an ongoing basis.