Qualifizierungsexpert*in (alle Geschlechter)
Core
Ensuring GMP-compliant use of production and HVAC (TGA) facilities and equipment through structured qualification and documentation.
Role type
Senior GMP Qualification Specialist
Builds
Qualification strategies and audit-ready documentation for pharmaceutical manufacturing
Domain
Pharmaceuticals / GMP-regulated manufacturing
Required skills
GMP qualification, risk analysis, IQ/OQ/PQ planning, documentation management, MS Office, ValGenesis, IQMS, SAP
Preferred skills
Master qualification, solid production experience with solid dosage forms
Technologies
ValGenesis, IQMS, SAP
Responsibilities
Create GMP documents for qualifications and periodic reviews; plan and coordinate qualification/requalification tests; execute and document tests; develop and optimize qualification strategies; manage quality-relevant documents
Seniority
Senior, hands-on IC
