Pharmaceutical Specialist for Release File Preparation | Pharma: Spezialist m/w/d für die Vorbereitung von Release-Dateien 31,77€ plus Prämien
apero GmbH Arbeitnehmerüberlassung
Job Summary
This specialist role within the clinical study team focuses on the critical task of independently compiling and managing release documentation (Release Files) for a prominent pharmaceutical client in Biberach an der Riß. You will act as the primary representative for Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities, ensuring strict adherence to legal and regulatory guidelines, particularly within GMP-regulated environments. A key part of the role involves serving as a Subject Matter Expert (SME), evaluating risks, proposing process improvements, and contributing to innovation projects. Furthermore, you will support internal inspections by preparing necessary documents and presenting relevant processes from your area of responsibility. Success in this position requires a background in natural sciences, strong knowledge of pharmaceutical development, proficiency with SAP and MS Office systems, and proactive, targeted communication skills in both German and English.
Required Skills
Education
Master's degree in Natural Sciences, OR Bachelor's degree in Natural Sciences, OR Natural Science vocational training combined with Master Craftsman/Technician qualification.
Experience
- Professional experience in GMP-regulated environments in pharmaceutical development
- Several years of relevant professional experience (required if holding a Bachelor's degree or vocational training qualification)
Languages
Additional
- Location in Biberach an der Riß; Position offered via temporary employment (Arbeitnehmerüberlassung) with generally permanent contract.
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