Release File Preparation Specialist for Clinical Studies | Naturwissenschaftler für Freigabedokumentation klinische Studien (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This opportunity is for a scientifically-minded professional to join a globally successful pharmaceutical company as a Release File Preparation Specialist for Clinical Studies in Biberach, Germany. In this crucial role, you will manage the compilation of all necessary release documentation within the clinical study team. Key responsibilities involve creating the Supply Chain Document, selecting appropriate release scenarios, and guaranteeing the timely provision of all relevant materials while strictly adhering to all legal and regulatory frameworks, including GMP. You will also act as a Subject Matter Expert (SME) on innovation projects, contributing ideas for process optimization and supporting internal inspections. Candidates must possess a Master’s degree in Natural Sciences (or equivalent relevant professional experience), expertise in GMP-regulated environments, and fluent communication skills in both German and English. This position offers a responsible role with opportunities for continuous professional development.
Required Skills
Education
Master's degree in Natural Sciences, or Bachelor's degree in Natural Sciences with relevant professional experience, or completed natural science training with long-term, relevant experience
Experience
- Experience in GMP-regulated environments (pharmaceutical development or manufacturing)
- Several years of relevant professional experience (required if holding a Bachelor's degree or non-academic natural science qualification)
Languages
Additional
- Full-time commitment
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