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The Company Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
Role Description As a Quality Assurance Specialist you will oversee and support the quality systems, projects, manufacturing activities and facilities.
Responsibilities
- Ensuring that clinical drug substance and associated manufacturing and testing activities comply with cGMP requirement, policies and procedures
- 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)
Requirements
- 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
Other Information This role is for 24 hours per week and 5 months. Open to freelancers. For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
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