Specialist for Release File Preparation | Spezialist m/w/d für die Vorbereitung von Release-Dateien 31,77€ plus Prämien
apero GmbH Arbeitnehmerüberlassung
Job Summary
This specialist role, based in Biberach an der Riß within the pharmaceutical industry, involves taking responsibility for the independent compilation of release documentation within clinical study teams. Key daily tasks include representing and managing Clinical Trial Manufacturing and Release File Preparation (CTM RFP) activities, ensuring strict adherence to legal and regulatory requirements. The specialist will also evaluate risks, develop improvement proposals, and act as a Subject Matter Expert in various innovation projects. Qualified candidates must possess a relevant natural science degree (Master's or Bachelor's with extensive experience) or an equivalent technical qualification, coupled with significant experience in GMP-regulated pharmaceutical development environments. Success requires strong organizational skills, proficiency in MS Office and SAP systems, and proactive communication in both German and English.
Required Skills
Education
Master's degree in Natural Sciences, or Bachelor's degree in Natural Sciences with several years of relevant professional experience, or completed natural science vocational training with additional certification as a Master Craftsman or Technician, plus several years of professional experience.
Experience
- Several years of relevant professional experience, preferably in the pharmaceutical industry
- Experience in GMP-regulated environments in pharmaceutical development
- Experience working as a Subject Matter Expert
Languages
Additional
- Unrestricted employment contract (unbefristet). Location: Biberach an der Riß.
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