Quality Control Scientist SHPGJP00008330
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)
About the company
