Quality & Change Coordinator | Quality & Change Koordinator * Roche Mannheim
Franz & Wach Personalservice PEN
Job Summary
This role offers an exciting opportunity to join Roche Diagnostics GmbH in Mannheim through Franz & Wach, focusing on quality assurance and change management within the pharmaceutical sector. The successful candidate will primarily support packaging material experts in refining risk management structures for reagent containers, including preparing and moderating workshops to develop various Failure Mode and Effects Analyses (FMEAs). Responsibilities also involve standardizing and maintaining FMEAs throughout the product lifecycle, and assisting in creating quality requirement documents such as test instructions and plans. This position is ideal for a detail-oriented professional with a scientific or engineering background and strong experience in risk analysis and quality planning within a regulated environment, particularly in plastics processing.
Required Skills
Education
University degree in Natural Sciences, Engineering, or equivalent
Experience
- Professional experience in quality and change coordination, specifically with risk management structures and FMEA creation
- Experience in creating product and process risk analyses (FMEA), preferably with APIS software (nth)
- Experience in quality advance planning within a regulated environment
- Comprehensive experience in plastics processing, especially injection molding and extrusion blow molding
Languages
Additional
- Not specified
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