Release File Preparation Specialist Pharma | Release File Preparation Specialist Pharma (m/w/d)
akut... Kompetente Lösungen GmbH
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
Additional
- Temporary position for 18 months starting October 1, 2025, with option for extension.
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