Release File Preparation Specialist Pharma | Release File Preparation Specialist Pharma (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role involves independently compiling release documentation within the clinical study team, 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. They will also act as a Subject Matter Expert in various improvement and innovation projects, and support internal inspections by providing documentation and presenting processes. This position requires a strong background in natural sciences, experience in GMP-regulated pharmaceutical environments, and proficiency with MS-Office and SAP systems. It's an opportunity to join an innovative pharmaceutical company, receive thorough training, and pursue professional development in a supportive team environment.
Required Skills
Education
Master's degree in Natural Sciences or Bachelor's degree in Natural Sciences with relevant professional experience; alternatively, completed natural science vocational training with further qualification as a Master or Technician.
Experience
- Professional experience in GMP-regulated environments within pharmaceutical development
- Several years of relevant professional experience, preferably in the pharmaceutical industry (if Bachelor's degree)
- Several years of professional experience (if vocational training with further qualification)
Languages
Additional
- Temporary position for 18 months, with an option for extension, starting October 1, 2025.
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