GMP Specialist (Biopharmaceutical Production) | GMP Spezialist (m/w/d)
Randstad Professional
Job Summary
This role is ideal for an experienced GMP Specialist seeking a secure and responsible position within the pharmaceutical industry in Biberach. The specialist will primarily focus on the GMP review of electronic manufacturing instructions (Master Batch Records) for batch documentation in biopharmaceutical production, covering both Upstream and Downstream processes, utilizing the BioMES 8 software. Key responsibilities include independently planning and executing controls of electronic manufacturing instructions and accompanying documents, maintaining master data in BioMES 8 and SAP, and performing administrative duties such as creating internal training materials, handling Change Control applications, and assisting with audits. Candidates must possess a scientific or engineering degree, or relevant vocational training with significant professional experience, coupled with strong IT affinity and proven experience in a GMP environment.
Required Skills
Education
Bachelor's degree in a natural science field (e.g., Biotechnology, Process Engineering, Chemical Engineering) or comparable, or completed scientific vocational training (e.g., Pharmaceutical Technician, Chemical Technician) potentially supplemented by further training as a Technician or Industrial Master.
Experience
- Professional experience in the pharmaceutical industry or other large-scale manufacturing operations
- Experience in a GMP environment
- Professional experience with a good understanding of production processes
Languages
Additional
- Not specified
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