engineering people GmbH
Specialist Quality Assurance GMP (m/w/d)
Ulm, Donau, Baden-Württemberg, Germany
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hirly's read of this role
- Role family
- Engineering
- Seniority
- Mid level
- Stated salary
- €60,000 – €70,000 per year
- Country
- DE
- Work mode
- On-site / unstated
- First seen by hirly
- 4 Nov 2026
Derived automatically from the posting. Upload your resume above to see how the role scores against it.
the posting
- Aufgaben:
- GMP-konforme Prüfung und Freigabe von Herstell- und Verpackungsdokumentationen sowie Chargendokumentationen
- Durchführung von Batch Record Reviews
- Bearbeitung, Bewertung und Nachverfolgung von Abweichungen, GMP-Ereignissen sowie OOS
- Initiierung, Nachverfolgung und Wirksamkeitsprüfung von Corrective and Preventive Actions Maßnahmen
- Unterstützung bei Change Controls, Risikoanalysen und Qualitätsbewertungen
- Review von SOPs, Herstellvorschriften und GMP-Dokumentationen
- Unterstützung bei Audits und Inspektionen
- Profil:
- Studium im Bereich Biotechnologie, Biologie, Pharmazie, Chemie oder vergleichbare Qualifikation
- Erfahrung in biopharmazeutischer Produktion, Quality Assurance oder Quality Control
- Kenntnisse in Batch Records, Deviations, Corrective and Preventive Actions, Change Controls und Chargenfreigaben
- Kenntnisse der europäischen GMP-Richtlinien und relevanter Qualitätsmanagementsysteme
- sorgfältige, strukturierte und qualitätsorientierte Arbeitsweise
- sehr gute Deutsch- und gute Englischkenntnisse
Listed on hirly, a job board. hirly is not the employer: engineering people GmbH is hiring for this role.
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