Our client is one of the global leader in healthcare and pharmaceutical products, based in Leiden.The company focuses on the discovery, development, manufacture, and marketing of biologicals. They are part of a large organisation with several national and international affiliates.
This group is responsible for Sample Management and execution of all analytical test methods using various techniques. Sample Management will support in process control and both product release and stability..
We are looking for a Technical Specialist who can support the required Sample Management activities and, additionally, will actively handle quality and compliance related topics. Including deviations, CAPA, NPI GAP assessments and Change Controls.
- Responsible for Sample Management process to support execution activities in an efficient way. Following cGMP guidelines and safety procedures.
- Performing GAP analysis, protocols and reports performed during new product implementation
- Expert on Sample Management and will represent the team during internal and external meetings
- Act as a Subject Matter Expert during audits and inspections
- Participate or lead special projects or studies and support short- and long-term projects
- Driving continuous improvement processes
- Minimal Bachelor's Degree
- At least 2-4 years' of (bio-)pharmaceutical experience
- Expert in Sample Management
- Good technical writing skills in English
- Strong knowledge of statistical data analyses
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