vor 2 Tagen

QC investigations Scientist

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QC investigations Scientist

For our client specialized in Biotechnology, localized in the French part of Switzerland, we are looking for a :

QC Investigations Scientist

Your mission
Manage life cycle activities of analytical assays performed in the QC laboratories with a focus on laboratory investigations. And lead laboratory method validations, transfers, improvement projects and supports complex multi-sites investigations.

Your responsibilities

  • Identify and lead problem-solving and improvement projects using DMAIC approach
  • Coordinate investigations on out-of-specification, out-of-limit, and out-of-trend analytical results, etc.
  • Write validation protocols and reports for analytical methods
  • Write qualification plans and reports for critical reagents and reference standards
  • Oversee validation and qualification activities executed by QC analysts, provide training and support
  • Coordinate transfer or reception of QC sample units
  • Write assignment plans and reports for method controls, establish and perform evaluation of control charts
  • Support and prepare audit responses and regulatory submissions
  • Participate in multi-site projects as local project lead, working in collaboration with other QC scientists and Analytical Development groups

Your profile

  • Master Engineer or PhD in Chemistry, Biochemistry or Biotechnology Minimum a 5-year experience in pharmaceutical company GMP laboratory activities
  • Fluent in French, very good level in English
  • Good knowledge of analytical method validation and critical reagent qualification
  • Experience in problem solving (facilitation and application of DMAIC tools)
  • Good knowledge of regulatory requirements concerning analytical test methods and licenses

Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay.

rue du Rhône 114 1204 Geneve