Senior Compliance Specialist | Senior Compliance Specialist (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
As a Senior Compliance Specialist in an innovative pharmaceutical company, you will be crucial in ensuring regulatory adherence within the aseptic filling of Drug Product. Your daily responsibilities include implementing internal and regulatory requirements, coordinating closely with Quality and production staff. You will independently develop production procedures, leveraging the expertise of manufacturing personnel and technical coordinators. A key part of the role involves identifying and executing process improvements as the Change Control Owner, drafting critical regulations and risk analyses, and managing deviations. The ideal candidate holds a degree (Master/Bachelor) in a natural science field such as Pharmacy or Biochemistry, coupled with several years of professional experience in a GMP-regulated environment, specifically within biotech production or quality control. Success requires strong organizational skills, high initiative, and fluency in both German and English. This is an excellent opportunity for professional development within a motivated team, initially offered as an 18-month contract with potential for extension.
Required Skills
Education
University Degree (Diploma, Master, or Bachelor) in Biochemistry, Biopharmacy, Biology, Chemistry, Pharmacy, or a related natural science field.
Experience
- Several years of professional experience in Biochemistry, Biopharmacy, Biology, Chemistry, or Pharmacy
- Professional experience in biotechnological production, quality assurance/control, or technology within a GMP-regulated environment
- Foundational knowledge of GMP regulations
Languages
Additional
- Initially temporary contract for 18 months with the option for extension; Position starts September 1, 2025.
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