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.
Responsibilities
* 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.
Qualifications
* 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.
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