Quality Control Scientist

Start date: ASAP

Duration: 6 months/possible extension

Validation and Qualification Activities

• Author transfer protocols and reports for assays
• Author qualification plans and reports for critical reagents
• Oversee validation and qualification activities executed by analysts, provide
• Execute and documents experiments

Investigation Leads

• Investigate and trouble shoot problems which occur to determine solutions or
• Recommendations for improvements or change
• Conduct/participate in risk assessments, root cause analysis and investigations
• Own Laboratory Investigations and CAPA

Quality Control Support Activities

• Support the application of industry specific compliance standards/regulations to
• Assays life cycle management activities
• Participate to daily activities upon request (provide technical and statisticalsupport)

Experience Required

• University or engineering degree in analytical chemistry, biotechnology, biochemistry
• 2 years of experience in GMP
• Experience in Validation management is mandatory
• Experience in authoring protocols is mandatory
• Very good knowledge of method transfer
• Very good knowledge of critical reagent qualification
• Experience in problem solving and deviation management
• Good Knowledge of statistical tools
• Fluent in French and English (C1 written and spoken)