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 1, 2025
Full-time
No information

Job Summary

As a Release File Preparation Specialist in Pharma, you will play a crucial role within the clinical study team, independently compiling release documentation and representing Clinical Trial Manufacturing/Release File Preparation (CTM RFP) activities. This involves ensuring compliance with legal and regulatory requirements, evaluating risks, and proposing improvements. You will also act as a Subject Matter Expert in improvement and innovation projects and support internal inspections by providing documents and presenting processes. The ideal candidate will possess a Master's degree in natural sciences or a Bachelor's with relevant professional experience, particularly in the pharmaceutical industry, coupled with expertise in GMP-regulated environments and strong communication skills in both German and English. This role offers a responsible position in an innovative pharmaceutical company with opportunities for professional development and a supportive team environment.

Required Skills

Education

Master's degree in natural sciences or Bachelor's degree in natural sciences, or natural science training with additional qualification as Master or Technician

Experience

  • Professional experience in GMP-regulated environments in pharmaceutical development
  • Several years of relevant professional experience, preferably in the pharmaceutical industry (if Bachelor's degree)
  • Several years of professional experience (if natural science training with Master/Technician qualification)

Languages

German (Fluent)English (Fluent)

Additional

  • Temporary position for 18 months starting October 1, 2025, with option for extension.