Sachkundige Person (m/w/d)* gemäß §14 AMG (Teilzeit, 25%)
Core
Qualified Person (QP) responsible for final release of medical cannabis drug batches and ensuring compliance with EU GMP and German regulations.
Role type
Senior, hands-on IC (Qualified Person)
Builds
Medical cannabis pharmaceutical products
Domain
Healthcare / Pharmaceutical / Cannabis Medicine
Required skills
EU GMP knowledge, German AMG/MedCanG regulatory expertise, batch release certification, supplier and contract manufacturer audits, deviation and change management, complaint handling, internal audit execution, release register management
Preferred skills
Experience in cannabis medicine manufacturing, structured decision-making in complex processes
Technologies
None stated
Responsibilities
Certify batch releases according to AMG and MedCanG, validate manufacturing and testing procedures, audit suppliers and contract manufacturers, manage complaints and conduct self-inspections, maintain the release register
Seniority
Senior, hands-on IC
