Senior Technical Specialist
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 the execution of all analytical test methods using various Separations and Chemical/Physical techniques. Analytical data will support in process control and both product release and stability studies.techniques.
We are looking for a Senior Technical Specialist who can support the Separations and Chemical Physical techniques and, additionally, will actively handle quality and compliance related topics. Including deviations, CAPA, NPI GAP assessments and Change Controls.
- Responsible for ensuring that assays can be executed by the departments concerned, ensuring cGMP compliancy and safety
- 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 4-6 years' of (bio-)pharmaceutical experience
- Expert in Separations and Chemical/Physical techniques
- Good technical writing skills in English
- Strong knowledge of statistical data analyses
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