Release File Preparation Specialist | Release File Preparation Specialist (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This role involves the independent creation and compilation of release documentation for clinical studies, ensuring compliance with regulatory requirements and timelines. The specialist will represent CTM-RFP activities within study teams, contributing expertise to documentation and release processes. A key aspect of the role is risk assessment and the development of improvement suggestions for these processes. The ideal candidate will also act as a Subject Matter Expert in improvement and innovation projects, and support internal inspections by providing relevant documentation and presenting processes. This position is attractive for professionals passionate about Pharma and Life Science, offering opportunities for taking on responsibility and professional development within a supportive team environment.
Required Skills
Education
Completed scientific degree (Master or Bachelor with relevant professional experience) or vocational training with further education (Master Craftsman/Technician)
Experience
- Professional experience in the pharmaceutical industry (if Bachelor's degree) or several years of experience (if vocational training with further education)
- Initial experience in GMP-regulated areas, especially in pharmaceutical development
Languages
Additional
- Not specified
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