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The Company 
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.

Role Description 
The QA Officer acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation.

Responsibilities
- Review and approve change controls, validation protocols and reports, validation assessments, URS, and applicable lifecycle documentation
-Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation
- Work in close collaboration with other departments (Operations, QC, Engineering, RA, etc.)


Requirements 
BSc/HBO degree in bioscience, chemistry, pharmacy or equivalent;
- 2years' of QA experience in pharmaceutical or related industry 
- Knowledge of current GMP regulations
- Experience in Change control and all documenting related activities 
- Experience with documentation systems like Trackwise, True Vault 
- Experience with Systems like Delta-V, Scada, PAI or MES 


Other Information 
For more information please contact Guilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.