Stability Scientist
Fast Track Diagnostics Ltd
Luxembourg
il y a 7m

Your responsibilities :

  • Work as member of 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, etc.
  • according to the ISO 13485

  • Ensure the successful completion of equipment qualifications, process validations if needed
  • Responsible for equipment monitoring, calibration and support maintenance if needed
  • 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)
  • 60% practical work in laboratory and 40% office work
  • Perform QCMD, NEQAS, INSTAND panels for post market surveillance
  • Techniques to be used : extraction of DNA / RNA on different platforms (NucliSENS® easyMAG® and others), performance of real time PCR on several devices (Applied Biosystems® 7500, QuantStudio 5™, VERSANT® kPCR AD module, and others) and manual / automatic analysis of PCR run files
  • Compliance with ISO 13485 : 2016
  • 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
  • Willing to work in an international team within a highly collaborative environment
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