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As a MES Quality Engineer, you are responsible for the review and approval of Master Batch Records and Recipes to ensure the timely production of our commercial API portfolio, while guaranteeing compliance with GMP and other applicable regulations. You will work closely with Business and Quality partners to ensure that our production systems and documentation meet the highest quality standards.
Job Responsibility
Review and approve Master Batch Records for commercial APIs
Review and approve MES Recipes, ensuring accuracy, consistency, and regulatory compliance
Write, review, and approve QA procedures and related documentation
Provide quality support for smaller optimization projects and continuous improvement initiatives within the QA Commercial Operations team
Ensure that MES-related changes are properly assessed from a quality perspective and implemented in a compliant manner
Collaborate closely with Production, Engineering, IT, and other Quality functions to resolve issues and optimize processes
Contribute to investigations, deviations, CAPAs, and change controls related to MES, Master Batch Records, and Recipes
Foster and maintain strong, collaborative relationships with Business and Quality partners across the site
Requirements
Bachelor’s degree or higher in sciences (e.g., Chemistry, Biology, Pharmacy, Information Technology, Engineering, or related field)
4–6 years of experience (mid-level) in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance
Strong understanding of production systems and their operation in a GMP environment
Proven track record of working independently while maintaining effective communication with key stakeholders
Proficiency with the PAS-X Manufacturing Execution System (MES) is MANDATORY
Strong analytical and critical thinking skills with a solutions-oriented mindset
High level of accuracy and attention to detail
Quality-focused mindset and strong sense of ownership and accountability
Excellent communication and stakeholder management skills
Fluent in Dutch and English
Nice to have
Experience in an international or matrix organization
Prior experience in a Launch & Grow or similar high-change environment