Compliance Specialist | Compliance Specialist (m/w/d)
Randstad Professional
Job Summary
This role is for a proactive Compliance Specialist in the pharmaceutical industry, focusing on Clinical Supply Biologics. The specialist will independently create, coordinate, and manage Change Controls, acting as the primary contact for GMP topics and Change Controls within their area. They will actively participate in cross-operational and cross-departmental compliance projects, and provide crucial support during audits and inspections by preparing necessary documentation and addressing compliance questions in both German and English. The ideal candidate will possess a strong background in biotechnology, chemistry, or pharmacy, coupled with excellent communication, planning, and organizational skills, ensuring close collaboration with operations management, production, and quality units.
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
- Strong knowledge of regulations concerning clinical sample manufacturing
- Proven assertiveness for goal-oriented completion of quality events
Languages
Additional
- Not specified
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