Release File Preparation Specialist Pharma | Release File Preparation Specialist Pharma (m/w/d)

akut... Kompetente Lösungen GmbH

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Sep 19, 2025
Full-time
No information

Job Summary

This role involves independently compiling release documentation within clinical study teams, ensuring compliance with legal and regulatory requirements. The specialist will represent Clinical Trial Manufacturing/Release File Preparation (CTM RFP) activities and timelines, evaluate risks, and propose improvements. As a Subject Matter Expert, you will contribute to various improvement and innovation projects and support internal inspections by providing documents and presenting processes. This position offers a challenging opportunity in an innovative pharmaceutical company, with a focus on professional development and a supportive team environment. The ideal candidate will have a natural science degree or relevant professional experience, particularly in the pharmaceutical industry, and strong organizational and communication skills.

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 further education as a Master Craftsman or Technician

Experience

  • Several years of relevant professional experience, preferably in the pharmaceutical industry (if Bachelor's degree)
  • Professional experience in GMP-regulated environments in pharmaceutical development

Languages

German (Fluent)English (Fluent)

Additional

  • Temporary position for 18 months, with an option for extension (starting October 1, 2025)