Release File Preparation Specialist, Pharma | Clinical Trial Manufacturing | Release File Preparation Specialist (m/w/d) Pharma | Clinical Trial Manufacturing

Job Summary

This role involves independently compiling release documentation and acting as the primary representative for Clinical Trial Manufacturing/Release File Preparation activities within clinical study teams. The specialist will ensure compliance with legal and regulatory requirements, evaluate risks, and propose improvements. This position also entails serving as a Subject Matter Expert in various improvement and innovation projects and supporting internal inspections by providing documentation and presenting processes. The ideal candidate will possess a scientific master's or bachelor's degree with relevant pharmaceutical industry experience, or a scientific vocational qualification with further training, coupled with experience in GMP-regulated environments. Strong communication skills in both German and English are essential, along with proficiency in MS-Office and SAP-based systems.