QA Engineer Alliance Product

• The QA Engineer acts as the day-to-day liaison with internal and external customers for quality related activities.
• Ensure GMP compliance of Sanofi products manufactured and/or tested at a contract facility.
• 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 product meet Sanofi and GMP requirements.
• Contribute to the completion of milestones associated with specific projects.
• Review batch abstracts to release product 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 manufacture of medicinal products (biologics).
• Manage notification flows in quality systems between internal and external partners
• Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
• Provide guidance to less experienced staff, as applicable.

• Uitdagende projecten in lijn met jouw interesses en talenten
• Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
• Mogelijkheid tot het volgen van extra opleidingen
• Inspirerende netwerkevents en legendarische afterwork drinks
• Sterk netwerk van toonaangevende klanten
• Expertise binnen IT, Engineering en Life Sciences
• Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Have you got what it takes?

• Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, whereof 3 years in a quality role. Experience in a regulatory affairs (RA) role is a plus
• Excellent communication and organizational skills.
• Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right firsttime).
• Being fluent in English is a requirement (writing & speaking), Dutch is a plus