QA Engineer

CONSULTYS BENELUX is looking for a QA Engineer to reinforce its consulting team.

The role of an QA Engineer is to act as the day-to-day liaison with internal and external customers for quality-related activities and ensure GMP compliance of products manufactured and/or tested at a contract facility.

YOUR MAIN DUTIES:

• 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.
• Review batch abstracts to release products in accordance with approved specifications and procedures.
• 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.
• Demonstrate understanding of applicable regulations related to the manufacture of medicinal products (biologics).
• Manage notification flows in quality systems between internal and external partners
• Monitor contractor performance to establish Key Performance Indicators (KPIs) and report adverse trends.

ABOUT YOU:

• 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
• Excellent communication and organizational skills
• 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

ABOUT US:

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.

We cultivate a human-scale company spirit that allows us to personally follow our 550 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium, Canada and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts.

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.