Requirements: English
Company: CONSULTYS BENELUX
Region: Arlon , Wallonia
CONSULTYS BENELUX is looking for a QA Engineer toreinforce its consulting team. The role of an QA Engineer is to actas the day-to-day liaison with internal and external customers forquality-related activities and ensure GMP compliance of productsmanufactured and/or tested at a contract facility. YOUR MAINDUTIES: - Ensure all aspects of product manufacturing and/ortesting are reviewed versus established - quality standards and theapplicable marketing authorizations. - Manage quality systems, e.g.change control, deviations, and product investigations. - Modify,review, and ensure contractor quality standards and protocols forprocessing materials into partially finished or finished productsmeet GMP requirements. - Review batch abstracts to release productsin accordance with approved specifications and procedures. -Monitor contractor compliance via GxP documentation review andon-site visits/audits. - Distribute applicable contractordocumentation for Regulatory, Validation, and Subject Matter Expertreview. - Interact with multi-functional internal and externalproject teams to ensure compliance. - Respond to technical andquality issues and handle schedule and/or process-relatedconflicts. - Demonstrate understanding of applicable regulationsrelated to the manufacture of medicinal products (biologics). -Manage notification flows in quality systems between internal andexternal partners - Monitor contractor performance to establish KeyPerformance Indicators (KPIs) and report adverse trends. ABOUT YOU:- Bachelors or Master''s degree and at least 2 years of experiencein a cGxP or other regulated environment, including 1 year in aquality role - Excellent communication and organizational skills -Demonstrated ability to perform work requiring attention to detailand of high quality (i.e. right first time) - Fluency in English,Dutch and French is mandatory for the position ABOUT US: For morethan 15 years, the largest laboratories in the world have beenshowing their confidence in our company. Specialized in pharma,biotech and medical devices, we support our customers from researchto product launch. We cultivate a human-scale company spirit thatallows us to personally follow our 550 employees each of themknown for their technical and scientific expertise. Through ourregional subsidiaries in France, Belgium, Canada and Switzerland,we offer everyone geographical stability, without a mobility clausein the contracts. Do you want to integrate the consulting worldinto a human-sized company that values the individual and theperformance? Do you want to invest in long-term innovativeprojects? To share your skills in a close-knit team whereexperiences are shared freely? So, join us! We offer you anattractive salary and fringe benefits. You will work in astimulating international environment, with numerous opportunitiesfor personal development.