Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for human health.
This team is responsible for overseeing and supporting the quality systems, projects, manufacturing activities and facilities of different sites and external collaborations. As a Quality Assurance Specialist you are proactive and willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.
- Review and disposition of drug substance batches for clinical release
- QA Oversight for drug substance manufacturing and laboratory operations
- Issue and escalation management, CAPA design and root cause analysis support
- Review and approve cGMP documentation (SOP's, protocols and technical reports)
- Master's Degree in Science or Engineering
- At least 6 years' of QA experience
- 2 years' of experience in product disposition processes and requirements
- cGMP manufacturing and testing in biotechnology industry preferable in vaccines
- Solid knowledge on EU and global regulations, cGMP standards and ICH guidelines
Within this role you will work in a multidisciplinary and dynamic team, looking for a candidate with excellent communication skills and can work independently and organized.