Quality Assurance Specialist / Qualified Person Support (Pharmaceutical Industry) | Biotechnologe (m/w/d) Biochemiker (m/w/d) Verpackungsingenieur (m/w/d)
agento PersonalManagement GmbH
Job Summary
This role involves providing crucial procedural and administrative support to the Qualified Person (QP) responsible for Investigational Medicinal Products (IMPs) within a top global pharmaceutical company. The specialist will be primarily focused on ensuring regulatory compliance and quality assurance. Day-to-day tasks include meticulously reviewing release documentation for IMPs, verifying strict adherence to submitted regulatory documentation (CTAA), current Good Manufacturing Practice (cGMP), and internal quality instructions. You will be responsible for documenting review results and associated KPIs, supporting the subsequent certification process by the QP, and actively contributing to the continuous improvement and optimization of the release process and related systems. The position requires strong communication skills to efficiently collaborate with internal and external interfaces to resolve open issues. This is an attractive opportunity offering challenging, responsible work, equal pay to permanent employees (approx. €70,500 p.a.), a hybrid work model (2-3 days remote after onboarding), and excellent prospects for permanent employment.
Required Skills
Education
Master's degree in a scientific field (Biotechnology, Biochemistry, or similar) or completed vocational training in the pharmaceutical environment
Experience
- Intermediate professional experience in Pharmaceutical Development, Manufacturing, Packaging, Testing, Clinical Trial Authorization, or Quality Assurance (required with Master's degree)
- Several years of relevant professional experience (required with vocational training)
- Demonstrated ability to successfully, efficiently, and carefully process complex issues
Languages
Additional
- Entry via temporary employment with high potential for permanent takeover; Hybrid work model (2-3 days remote possible after consultation); Onboarding must take place on-site at the Biberach location.
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