Fresenius Kabi Norge AS

Fresenius Kabi Norge AS er en farmasøytisk bedrift i vekst. Vi produserer flytende legemidler i plastemballasje til hele verden. Selskapet har de siste årene hatt en positiv utvikling og omsetter i dag for over 1 mrd. NOK. I Norge har vi i dag en fabrikk i Halden og et markedskontor Oslo, og er i overkant av 600 ansatte.

Fresenius Kabi Norge AS inngår i det tyske konsernet Fresenius SE, med hovedkontor i Frankfurt, Tyskland. Konsernet har i dag i over 300 000 ansatte, i mer enn 100 forskjellige land rundt om i verden. For mer informasjon Se vår hjemmeside: Fresenius-kabi.com/no

Are you our new Quality System Engineer?

If you are excited to be part of a winning team and work in an international environment, we have
an opportunity for you.

You will work under the direction and supervision of the Halden Sr. Quality Systems Manager and lead the planning and execution of projects and activities for the facility to improve product and process quality. You will analyze quality data, such as complaints, process non-conformances, audit reports, deviations, OOSs, process capability, etc, to identify and correct quality issues.

Manage and support Change Control and Document Control processes driving improvement throughout of the facility.

You will be a key resource in identifying and implementing best practices for change management, problem solving, and driving customer satisfaction.

Responsibility:

  • The sites KabiTrack change control process and work with corporate KabiTrack Support
  • Execute day-to-day change control requests
  • Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system / GMP.
  • Review document changes for accuracy and compliance with the change process.
  • Work with peers within Halden and across Fresenius Kabi sites to improve and harmonize change management processes.
  • Be a qualified internal auditor and support all external audits

Education:

Qualified individual should have a bachelor’s degree in science in: Chemistry, Biology, Pharmacy, Engineering, Business, Mathematics, or technical field with emphasis on statistics and problem-solving skills. Advanced degree preferred.

Experience:

  • Minimum 4 years of experience in Quality Assurance or related field
  • Working experience with change control, deviations, and/or CAPA
  • Working Experience with EU or FDA cGMPs
    • 21 CFR part 211 or Part 820, ICH Q7, EU GMPs, or ISO13485 preferred
    • AS9100 or TS16969 Quality Systems will also be considered
  • Strong leadership, facilitation, and communication skills
  • Working knowledge 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:

  • Exposure to process and/or software validation methods
  • Demonstrated implementation of continuous improvement methodologies
  • ASQ Certificate: CQE, CQA, CQT, CBA, etc.
  • Lead Auditor Certification and Training
  • Quality auditor experience (or supplier auditor)
  • Operational Excellence/Six Sigma/Lean training or certifications
  • Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
  • Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc)
  • Experience using Sparta Trackwise
  • Experience using SAP

For more information about the position, please contact QA Director Wayne Aaron Snyder (Aaron.Snyder@fresenius-kabi.com) or Hilde Oppedal Olsen (hilde.olsen@fresenius-kabi.com).