Qualifizierungsexpert*in (alle Geschlechter)
Core
Develop and execute qualification strategies and GMP-compliant documentation for production and HVAC (TGA) facilities and rooms to ensure regulatory compliance.
Role type
Senior GMP Qualification Specialist
Builds
Qualification plans, risk assessments, and audit-ready documentation for pharmaceutical manufacturing facilities
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP qualification, GMP documentation, risk assessment, IQ/OQ/PQ planning, facility qualification, MS Office, ValGenesis, IQMS, SAP
Preferred skills
Master qualification, solid particle production experience, interdisciplinary collaboration
Technologies
ValGenesis, IQMS, SAP
Responsibilities
Create GMP documents for qualifications and periodic reviews, plan and coordinate qualification tests, execute and document tests, optimize qualification strategies, manage quality documents
Seniority
Senior, hands-on IC