GMP Specialist | GMP Spezialist (m/w/d)
Randstad Professional
Job Summary
This role as a GMP Specialist involves meticulous review and control of electronic manufacturing specifications (Master Batch Records) crucial for batch documentation in biopharmaceutical production, covering both Upstream and Downstream processes. Daily tasks include utilizing specialized software like BioMES 8 and SAP for master data maintenance, planning and conducting document control checks, and handling administrative duties such as processing Change Control applications, conducting internal training, and assisting with audit preparation and accompaniment. The ideal candidate holds a Bachelor’s degree in Natural Sciences or equivalent vocational training combined with significant experience in the pharmaceutical or large-scale manufacturing industry, specifically within a GMP environment. Strong IT affinity, precise working methods, and fluency in both German and English are essential for success in this permanent position.
Required Skills
Education
Bachelor's degree in Natural Sciences (e.g., Biotechnology, Process Engineering, Chemical Engineering) or comparable; Alternatively, completed natural science vocational training (e.g., Pharmacist, Chemical Technician) potentially with further qualification (Technician, Industrial Master)
Experience
- Professional experience in the pharmaceutical industry or large-scale manufacturing operations
- Professional experience in the GMP environment
- Good understanding of production processes
- Several years of professional experience (if following the vocational training path)
Languages
Additional
- Not specified
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