Stability Scientist (M/F)

 

Your responsibilities: 

  • Work as a member in the quality management and quality control department
  • Support the QM and QC team in the tasks of generating and updating all relevant documentation (SOP, process instructions, manuals, ...) according to the ISO 13485.
  • Ensure the successful completion of equipment qualifications, process validations
  • Responsible for equipment monitoring, calibration and Maintenance
  • Perform internal audit and supplier's audit 
  • Stability studies
  • Management and update of certain quality relevant documents (e.g. development of sheet, table with sequences, tables with targets)
  • Random controls of produced products (RTU, ready kits)

 

Your profile: 

  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience 
  • Prior manufacturing or quality experience in molecular diagnostics
  • Good working knowledge of DIN EN ISO 23640, IVD medical devices and evaluation of stability of IV diagnostic reagents (ISO 23640:2011)
  • Knowledge of quality requirements (ISO 13485) 
  • Driven individual with a history of developing collaborative, cross-functional solutions 
  • Strong focus attention to details
  • Advanced knowledge of EXCEL and good command of MS office
  • Excellent written and spoken English language skills
  • Capacity for working independently
  • Excellent interpersonal and organizational skills
  • Will to work in an international team within a highly collaborative environment

 

The position will be based in Luxembourg.

 

If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:

 

Fast Track Diagnostics S.à.r.l.

Ms. Elisabeth CHACTOURA

29, rue Henri Koch- L-4354/ Esch s/ Alzette

e-mail: Elisabeth.Chactoura@fast-trackdiagnostics.com