Compliance Specialist | Compliance Specialist (m/w/d) - auch in 80% Teilzeit möglich
expertum GmbH - Niederlassung Biberach
Job Summary
This role is for a Compliance Specialist in the chemical/pharmaceutical sector, based in Biberach an der Riß, Germany, with options for full-time or 80% part-time work. The specialist will independently create, coordinate, and manage Change Controls within Clinical Supply Biologics, serving as the primary contact for GMP topics and Change Controls. Responsibilities also include active participation in cross-operational and cross-divisional compliance projects, as well as supporting audits and inspections by preparing documentation and addressing compliance queries in both German and English. The ideal candidate will have a background in biotechnology, chemistry, or pharmacy, with relevant professional experience in a GMP environment, strong communication skills, and the ability to work independently and responsibly.
Required Skills
Education
Bachelor's degree or Master's degree in Biotechnology, Chemistry, or Pharmacy; alternatively, a completed scientific education.
Experience
- Several years of professional experience with a Bachelor's degree in Biotechnology, Chemistry, or Pharmacy
- Initial professional experience with a Master's degree in Biotechnology, Chemistry, or Pharmacy
- Long-term professional experience in a GMP environment (e.g., production, quality assurance, quality control) with a scientific education
- Foundational knowledge of regulations concerning clinical sample manufacturing
- Strong assertiveness for goal-oriented completion of quality events
Languages
Additional
- Not specified
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