Specialist for Release File Preparation | Spezialist m/w/d für die Vorbereitung von Release-Dateien 5183€ plus Prämien
apero GmbH Arbeitnehmerüberlassung
Job Summary
This specialist role, based in Biberach an der Riß within the pharmaceutical industry, focuses on the independent compilation of release documentation for clinical study teams. Day-to-day responsibilities include representing and managing Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities, ensuring strict adherence to legal and regulatory guidelines. The specialist will also evaluate risks, develop improvement proposals, and act as a Subject Matter Expert in various innovation projects. A strong background in GMP-regulated pharmaceutical development environments is essential, along with proficiency in MS Office and SAP systems. The ideal candidate possesses a proactive, efficient, and careful work style, coupled with excellent communication skills in both German and English, making this a critical and highly regulated role in clinical study support.
Required Skills
Education
Master's degree in Natural Sciences, or Bachelor's degree in Natural Sciences with relevant professional experience, or Vocational training in Natural Sciences with further qualification as Master Craftsman or Technician.
Experience
- Professional experience in GMP-regulated environments in pharmaceutical development
- Several years of relevant professional experience, preferably in the pharmaceutical industry (required if holding a Bachelor's degree or vocational training)
Languages
Additional
- Not specified
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