Quality Management Associate | Mitarbeiter im Qualitätsmanagement(m/w/d)
IOZK AG
Job Summary
This role involves supporting the maintenance and continuous development of a Pharmaceutical Quality System within a specialized translational medicine center in Cologne. As a Quality Management Associate, you will handle day-to-day tasks such as processing quality incidents (deviations, OOS results), coordinating CAPA measures, and managing change control processes. You will also be responsible for Batch Record Reviews, root cause and risk analyses, and the preparation of qualification and validation documents. The position is ideal for professionals with a background in life sciences who want to work in an innovative medical environment focused on personalized cancer therapy. The role offers a high-end private clinic atmosphere, shift-free working hours, and a 13th-month salary. It is a unique opportunity to work at the intersection of immunology and advanced therapy medicinal products (ATMPs) while ensuring strict compliance with GMP guidelines.
Required Skills
Education
Successfully completed degree in natural sciences or equivalent training in the fields of Pharmacy, Medicine, Biology, or Chemistry.
Experience
- Initial professional experience in Quality Management or Quality Assurance
- Experience in pharmaceutical manufacturing and GMP environments
- Experience with root cause analysis and risk assessment in a collaborative setting
- Professional experience in handling deviations and OOS (Out of Specification) results
Languages
Additional
- The position is a fixed-term contract (Befristet). Candidates must provide a CV, cover letter, current references, and training certificates.