Quality Engineer | Quality Engineer (m/w/d)
Personalhansa Dienstleistungsges. mbH
Job Summary
This permanent position as a Quality Engineer, based in the Rhine-Neckar Metropolitan Region, involves ensuring the quality and compliance of clinical trial materials within the pharmaceutical industry. Key responsibilities include the GMP-compliant handling of product complaints, independently conducting and coordinating necessary laboratory investigations, and drafting comprehensive investigation reports. A critical function is defining appropriate Corrective and Preventive Actions (CAPA) and assessing the pharmaceutical impact on drug safety and quality. The role also requires significant administrative support for the release of clinical trial materials, preparing regulatory documents for import/export, clinical trial applications, and managing changes to manufacturing and import permits. Candidates must possess a university degree in a scientific field and several years of professional experience in pharmaceutical quality assurance or manufacturing, coupled with excellent knowledge of cGMP (EU, US) and international pharmaceutical law. Strong organizational, analytical, and problem-solving skills are essential for success.
Required Skills
Education
Scientific University or Technical College Degree
Experience
- Several years of professional experience in the pharmaceutical industry (Quality Assurance, Manufacturing, or Testing of medicinal products)
- Experience in drug development or handling clinical trial materials (preferred)
Languages
Additional
- Permanent contract; Must work in the Rhine-Neckar Metropolitan Region.
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