Engineer in opleiding
il y a 2 semaines
Ensure all aspects of product manufacturing and/or testing are reviewed versus established
quality standards and the applicable marketing authorizations.
Manage quality systems, e.g. change control, deviations, and product investigations.
Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished products meet GMP requirements.
Monitor contractor compliance via GxP documentation review and on-site visits/audits.
Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
Interact with multi-functional internal and external project teams to ensure compliance.
Respond to technical and quality issues and handle schedule and/or process-related conflicts.
Manage notification flows in quality systems between internal and external partners
Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.
Bachelor's or Master's degree and at least 2 years of experience in a cGxP or other regulated environment, including 1 year in a quality role
Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time)
Fluency in English, Dutch and French is mandatory for the position
For more than 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.
Through our regional subsidiaries in France, Belgium, Canada and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts.
To share your skills in a close-knit team where experiences are shared freely? You will work in a stimulating international environment, with numerous opportunities for personal development.
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