Senior Compliance Specialist | Senior Compliance Specialist (m/w/d)
expertum GmbH
Job Summary
This Senior Compliance Specialist role is crucial for maintaining regulatory adherence within the aseptic filling operations of Drug Product for a prominent client in the Chemistry/Pharma sector. The successful candidate will be responsible for translating internal and regulatory guidelines into actionable processes, collaborating closely with manufacturing and technical teams. A core function involves proactively identifying and implementing improvements in aseptic filling, often serving as the Change Control Owner. Day-to-day tasks include drafting essential regulations and risk analyses, managing deviations, and conducting necessary employee training to ensure compliance standards are met. This position requires a strong background in a GMP-regulated environment, coupled with a university degree in a natural science field like Pharmacy, Biochemistry, or Chemistry. Candidates must demonstrate excellent planning and organizational skills, along with fluent proficiency in both German and English, to drive critical quality and compliance initiatives within this high-stakes production environment.
Required Skills
Education
University degree in Biochemistry, Biopharmacy, Biology, Chemistry, or Pharmacy, OR natural science training with profound professional experience in relevant areas.
Experience
- Several years of professional experience in Biochemistry, Biopharmacy, Biology, Chemistry, or Pharmacy
- Professional experience in biotechnological production
- Professional experience in Quality Assurance/Quality Control (QA/QC) in a GMP-regulated environment
- Professional experience in technology within a GMP-regulated environment
Languages
Additional
- Not specified
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