Quality Engineer

Our client, a prominent player in the pharmaceutical industry, is seeking a Quality Engineer SM-API to act as a pivotal partner between operations and quality. This role involves overseeing quality advice and the review of documentation to ensure the compliant release of a diverse active pharmaceutical ingredient portfolio. The position focuses on maintaining high regulatory standards while supporting continuous improvement within a manufacturing environment.

• Review and approve non-conformances and CAPAs in support of the commercial operations team.
• Evaluate and approve GMP documentation, including procedures, work instructions, protocols, and reports.
• Provide operational quality support to production plants to ensure ongoing compliance.
• Manage quality records such as Change Controls by providing technical and compliance expertise.
• Execute quality check rounds and support optimization tasks within the quality assurance team.
• Maintain effective working relationships with cross-functional business and quality partners.

• You possess a Master’s degree in a scientific field such as Chemistry, Pharmaceutical Sciences, or Bioengineering.
• You have proven experience in handling non-conformances within a regulated supply chain or quality environment.
• You bring an in-depth understanding of pharmaceutical processes including qualification, validation, and manufacturing.
• You possess comprehensive knowledge of cGMP regulations, ICH guidelines, and Quality Systems.
• You’re an analytical thinker capable of making risk-based decisions under time pressure.
• You are fluent in Dutch and English.

Nice to Haves

• Prior experience as a release responsible professional within the pharmaceutical sector.
• Demonstrated experience supporting optimization projects within Quality Assurance operations.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.