Compliance Specialist | Compliance Specialist (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role seeks a proactive Compliance Specialist to join an innovative pharmaceutical company, initially on a 12-month fixed-term contract with the potential for extension. The core responsibilities involve coordinating and processing critical cross-departmental compliance documentation, specifically focusing on Change Controls and the qualification of materials, including packaging and disposables. The specialist will act as a subject matter expert, managing the creation of internal regulations and handling CAPA and deviation processes. A key aspect of the job is communication and decision presentation during internal processes, audits, inspections, and supplier inquiries, requiring fluency in both German and English. Candidates must possess a scientific background (Bachelor's with experience or Master's) or extensive vocational experience in sterile drug manufacturing, coupled with excellent knowledge of GMP requirements and strong organizational talent.
Required Skills
Education
Bachelor's degree in Natural Sciences (Chemistry, Biology, Biochemistry, Biotechnology, or Pharmaceutical Technology) or Master's degree in Chemistry, Biology, Biochemistry, Biotechnology, or Pharmaceutical Technology, or relevant vocational training
Experience
- Initial professional experience (required with a Bachelor's degree)
- Many years of professional experience in the manufacture of sterile medicinal products (alternative requirement)
- Professional experience in coordinating cross-departmental compliance processes
Languages
Additional
- Initial 12-month fixed-term contract with option for extension
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