Qualified Person (QP) / Sachkundige Person nach § 14 AMG (m/w/d) – Talent Community
Core
Responsible for the release and certification of clinical trial medicinal products to ensure quality and regulatory compliance for international clinical studies.
Role type
Qualified Person (QP) / Sachkundige Person
Builds
Clinical trial medicinal products and quality documentation for global clinical research
Domain
Life Sciences / Pharmaceutical Quality Assurance / Clinical Supply Chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical license (Apotheker/in), Qualified Person certification (§ 14 AMG / EU Directive 2001/83/EG), GMP compliance knowledge, regulatory affairs expertise, deviation analysis, audit management, SOP development, quality complaint handling, risk assessment
Preferred skills
Experience in pharmaceutical manufacturing, clinical trial product handling, external lab assessment
Technologies
GMP Annex 13, GMP Annex 16, AMG regulations
Responsibilities
Release and certify clinical trial medicinal products per AMG and EU GMP Annex 13/16; Decide on the usability of drug batches for clinical trials; Manage national and international customer projects in Quality Assurance; Review and approve manufacturing, quality, and validation documentation; Create Qualified Person Declarations; Approve and develop SOPs; Evaluate deviations and conduct root cause analysis; Handle quality-related complaints; Advise customers on regulatory and quality matters; Conduct and accompany internal, external, and international audits; Communicate directly with national and international authorities; Assess and approve external testing laboratories
Seniority
Mid-level, hands-on IC