Release File Preparation Specialist | Release File Preparation Specialist (m/w/d)
Randstad Professional
Job Summary
This role involves specialized documentation and regulatory compliance within a clinical study team for a renowned pharmaceutical company in Biberach/Rohrdorf. The specialist will be primarily responsible for compiling release documentation, creating the necessary Supply Chain documents, selecting appropriate release scenarios, and ensuring all relevant materials are provided on time. Key responsibilities also include independently representing team-related activities, managing timelines, and ensuring strict adherence to all legal and regulatory frameworks, particularly within GMP-regulated environments. The ideal candidate will hold a Master's degree in Natural Sciences or a Bachelor's with relevant experience, preferably in the pharma industry, and must possess excellent communication skills in both German and English. This is an excellent opportunity for a proactive professional to contribute to process improvement projects and support internal inspections, offering long-term job security and attractive benefits.
Required Skills
Education
Master's degree in Natural Sciences or Bachelor's degree in Natural Sciences with relevant professional experience, alternatively a completed vocational training in Natural Sciences with corresponding long-term, relevant experience.
Experience
- Several years of relevant professional experience, preferably in the pharmaceutical industry (if holding a Bachelor's degree or vocational training)
- Experience in GMP-regulated environments (pharmaceutical development or manufacturing)
Languages
Additional
- Not specified
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