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 hoved- kontor 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 QC Responsible for PQR and Trending??

If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you! In this role you will be responsible for QC input for Process quality review (PQR) and Annual Product Report (APR). You will also be responsible for trending in QC according to guidelines.

Main responsibilities

  • Responsible for establishing and maintenance of system for trending of analytics for raw material, finished goods, micro in QC and stability data for QA.
  • Responsible for establishing and maintenance of system for trending of QC process
    • Establish system for trending of product lead time
    • Establish system for trending of average time used on analyses
  • Responsible to deliver QC input to APR and PQR according to agreed timelines with QA.
  • Perform annual reassessments of control charts and propose adjustments to control limits/alert levels.
  • Apply SPC rules (Statistical Process Control) according to guidelines to evaluate results on batches under test against established control chart limits.
  • Continuously evaluate trends against OOX and other relevant parameters according to guidelines.
  • Continuously evaluate trends against deviations that are coming up
  • Create monthly trending report, and present monthly report information at monthly quality review.
  • Event and CAPA handling in Kabi Track
  • Support of other QC functions when need

 

Key Requirerments

Education:

  • Bachelor’s degree in chemistry, Microbiology or other relevant education can be evaluated based on experience in the relevant field

 Experience: 

  • In-depth knowledge and experience in Quality Control
  • Profound knowledge in Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/ISO 9001/ GDP as well as environmental, health and safety systems

Personal characteristics

  • Good analytical understanding
  • Collaboration and capacity to work cross functional/sites/cultures
  • Drive change, transparent and communicate clearly
  • Fluency in Norwegian and English

 

For more information about the position, please contact QC Director Jan Magnar Volle (jan-magnar.volle@fresenius-kabi.com)

 

Søknadsfrist 15. august 2021