Sachkundige Person (QP) / Qualified Person (m/w/d)
Core
Responsible for the quality and safety of pharmaceutical products, ensuring compliance with EU-GMP and German drug laws for patients worldwide.
Role type
Qualified Person (QP) / Sachkundige Person
Builds
Pharmaceutical products
Domain
Pharmaceuticals / Regulatory Compliance
Required skills
Pharmaceutical degree with licensure, GMP compliance knowledge, regulatory environment expertise, batch release certification, quality documentation management, external manufacturer oversight, product specification creation, GxP audit planning and execution
Preferred skills
Experience with contract manufacturers, regulatory authority interaction, international stakeholder management, SAP proficiency
Technologies
SAP
Responsibilities
Certify batches before market release, evaluate batch deviations, conduct Product Quality Reviews, manage Quality Agreements, oversee external contract manufacturers, create and maintain product documentation and SOPs, plan and execute GxP audits
Seniority
Senior, hands-on IC
