Senior Compliance Specialist | Senior Compliance Specialist (m/w/d)
expertum GmbH - Niederlassung Biberach
Job Summary
As a Senior Compliance Specialist, you will be instrumental in ensuring the aseptic filling of drug products adheres to internal and regulatory guidelines. Your day-to-day will involve collaborating with various departments to implement compliance standards, independently developing production processes by leveraging the expertise of manufacturing personnel and technical coordinators, and identifying and implementing improvements as a Change Control Owner. You will also be responsible for creating regulations and risk analyses, managing deviations, and conducting employee training. This role requires a strong background in biochemistry, biopharmacy, biology, chemistry, or pharmacy, coupled with significant professional experience in a GMP-regulated environment, particularly in biotechnological production or quality assurance.
Required Skills
Education
University degree in Biochemistry, Biopharmacy, Biology, Chemistry, or Pharmacy; or a scientific education with extensive professional experience in relevant areas.
Experience
- Several years of professional experience in biochemistry, biopharmacy, biology, chemistry, or pharmacy
- Professional experience in biotechnological production, quality assurance/control, and/or technology in a GMP-regulated environment
Languages
Additional
- Not specified
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