Analytical Transfer And Validation Specialist

vor 1 Woche


Neuchâtel, Schweiz AXEPTA SA Vollzeit

Responsibilities :

  • Manage comprehensive validation studies to ensure the performance of analytical methods 
  • Write and review analytical transfer/validation/verification protocols, data, reports, test methods and other related documentation 
  • Analyze and interpret results of validation studies and prepare detailed reports 
  • Act as technical expert in analytical matters for several projects within the department 
  • Develop new analytical methods as part of the product development program.
  • Manage the implementation of new raw materials by defining the required tests

 

Profil : 

  • Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment
  • At least 4 years' experience in project management, analytical transfer and validation
  • Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification
  • Fluent in French and English


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