For our client specialized in Biotechnology, localized in the French part of Switzerland, we are looking for a :
QC Investigations Scientist
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.
- 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
- 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
Please apply on-line. For more information, contact Ms Sophie Darthenay.