Specialist for Release File Preparation | Spezialist m/w/d für die Vorbereitung von Release-Dateien 5183€ plus Prämien
apero GmbH Arbeitnehmerüberlassung
Job Summary
This role is for a Specialist in Release File Preparation within a clinical study team for a pharmaceutical company in Biberach an der Riß, Germany. The successful candidate will be responsible for independently compiling release documentation, representing Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities, and managing timelines within clinical study teams, ensuring compliance with legal and regulatory requirements. Key responsibilities also include evaluating risks, developing improvement suggestions, and acting as a Subject Matter Expert in various improvement and innovation projects. The specialist will also support internal inspections by providing documents and presenting processes from their area of responsibility. This position offers an attractive opportunity to contribute to pharmaceutical development in a GMP-regulated environment.
Required Skills
Education
Master's degree in a scientific field, OR Bachelor's degree in a scientific field with several years of relevant professional experience, OR scientific vocational training with additional qualification as a Master Craftsman or Technician and several years of professional experience.
Experience
- Professional experience in a GMP-regulated environment in pharmaceutical development
- Professional experience in the pharmaceutical industry (if Bachelor's degree)
Languages
Additional
- Not specified
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