Qualified Person (QP) / Sachkundige Person nach § 14 AMG (m/w/d) – Talent Community
Core
Release and certify clinical trial preparations for international studies, ensuring compliance with EU GMP and AMG regulations to guarantee patient safety.
Role type
Senior regulatory quality assurance specialist (Qualified Person)
Builds
Clinical trial supplies and documentation for global pharmaceutical studies
Domain
Life Sciences / Clinical Research / Pharmaceutical Manufacturing
Required skills
Qualified Person (QP) certification, EU GMP compliance, AMG §14 knowledge, batch release certification, deviation analysis, audit management, regulatory documentation, SOP development, root cause analysis, German (fluent), English (fluent)
Preferred skills
Experience in clinical trial supply chain, manufacturing experience, audit leadership
Technologies
GMP Annex 13, GMP Annex 16, AMG §15
Responsibilities
Release and certify clinical trial preparations; make usage decisions for drug batches; manage national and international QA projects; review and approve manufacturing and validation documentation; create Qualified Person Declarations; develop and update SOPs; evaluate deviations and conduct root cause analysis; handle quality complaints; consult on regulatory matters; lead internal and external audits; communicate with authorities; evaluate external testing laboratories
Seniority
Senior, hands-on IC
