Compliance Specialist | Compliance Specialist (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role involves independently managing and coordinating Change Controls, serving as the central point of contact for GMP topics and Change Controls within the department. The specialist will actively participate in cross-departmental compliance projects and support audits and inspections. A key part of the role is providing robust support to the department, including preparing Change Controls and addressing compliance questions in both German and English. This position requires close collaboration with operations management, all production areas, and quality units. It's an excellent opportunity for a professional with a background in biotechnology, chemistry, or pharmacy to contribute to an innovative pharmaceutical company, with a focus on continuous professional development.
Required Skills
Education
Bachelor's or Master's degree in Biotechnology, Chemistry, or Pharmacy; alternatively, a scientific education.
Experience
- Several years of professional experience with a Bachelor's degree, or 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.
- In-depth knowledge of regulations concerning clinical sample manufacturing.
- Strong assertiveness for target-oriented completion of quality events.
Languages
Additional
- This position can be part-time (minimum 80%) and is initially limited to 18 months with an option for extension. Start date is September 1, 2025.
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