Our customer is one of the biggest producers of vaccines in the world. The company uses its extensive and innovative technology to combat life-threatening diseases such as Corona, HIV and Ebola.
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 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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