Pharma 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 role involves acting as a Specialist within a clinical study team, primarily responsible for independently compiling and preparing release documentation for clinical trials within the pharmaceutical industry. Key day-to-day tasks include representing Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities, managing timelines within clinical study teams while ensuring strict adherence to legal and regulatory requirements, and proactively evaluating risks to develop improvement suggestions. The specialist will also serve as a Subject Matter Expert, contributing to various improvement and innovation projects, and supporting internal inspections by providing documentation and presenting processes. The ideal candidate must possess a Master's or Bachelor's degree in a natural science field with relevant professional experience, particularly in GMP-regulated environments, and demonstrate strong communication skills in both German and English.
Required Skills
Education
Master's degree in Natural Sciences, or Bachelor's degree in Natural Sciences, or vocational training in Natural Sciences with further qualification as a 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 (if holding a Bachelor's degree or vocational training)
Languages
Additional
- Not specified
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