Quality Engineer SM-API

Quality Engineer SM-API | Geel, Belgium | Hybrid

A leading pharmaceutical manufacturing site in Geel is looking for a Quality Engineer SM-API to join the Supply Chain Quality team supporting the final release and quality oversight of commercial SM-APIs. The role sits at the interface of Operations and Quality and is focused on maintaining compliant, reliable supply in a highly regulated environment.

Responsibilities

• Review and approve non-conformances and CAPAs in support of the QA Commercial Operations team.

• Review and approve GMP documentation, including procedures, work instructions, protocols, and reports.

• Provide quality support to the production plants and act as a key quality partner for Operations.

• Ensure quality records such as Change Controls are processed on time and in compliance, using quality, compliance, and technical expertise.

• Participate in QA check rounds.

• Support smaller optimization projects and tasks within the QA Commercial Operations team.

• Build and maintain strong working relationships with Business and Quality stakeholders.

Qualifications

• Master’s degree in a scientific discipline such as chemistry, pharmaceutical sciences, bioengineering, or equivalent.

• Experience in chemical and/or pharmaceutical supply chain and/or quality assurance is an asset.

• Experience as release responsible is an asset.

• Non-conformance handling experience is a must.

• In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage, and distribution processes.

• Strong analytical, solution-oriented mindset with the ability to work independently and under time pressure.

• Ability to make risk-based decisions under pressure.

• In-depth knowledge of cGMP, ICH guidelines, policies, standards, and procedures.

• Experience with quality systems.

• Fluent in Dutch and English, spoken and written.

• Regular on-site presence in Geel required under a hybrid working model.