Quality Officer

A Dutch and English speaking Quality Officer is required by our client, one of the world's largest pharmaceutical companies to work in their API manufacturing facility in the Netherlands. Supporting a Responsible Chemist, this individual will be responsible for reviewing Change control management and deviation management including CAPA's and risk analysis. This is a 5 month contract starting as soon as possible.

Key Duties:
Change control management: assessing changes in quality standards.
Changes in such processes (chemical and biochemical), analytical methods and specifications. The Responsible Chemist plays a key task in any amendment because he/she assesses the impact of the proposed amendment on compliance.
Participating in compliance team meetings, to document the impact of the change control system.
Deviation management: During production of APIs abnormalities occur. This involves both process deviations and product defects that emerge in the analysis of the final product.
Liaise with internal stakeholders to collate information regarding deviations for the Responsible chemist to review and act on accordingly.
Perform risk analysis and CAPA plans to deviations in chemical and biochemical API production.

Experience required:
HBO/WO education.
Long-term experience in pharmaceutical production environment and sound knowledge of GMP.
Knowledge of QA processes (particularly change control management and deviation management).
Knowledge of analytical processes and methods in Quality Control of API production.
Preferably knowledge of biochemical processes (purification of APIs from biological materials).
Fluency in Dutch and knowledge of English at a good level.

This is a great opportunity to work in for one of the world's largest pharmaceutical companies in their thriving API manufacturing organisation and in return offers exceptional rates