Qualified Person Manager (Határozott időre)
Core
Leading the Qualified Persons (QP) team to ensure GMP compliance and authorize the release of medicinal products for EU/EEA markets.
Role type
Senior Quality Assurance Manager (Qualified Person)
Builds
Medicinal products for EU/EEA markets
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, Qualified Person (QP) authorization, batch documentation review, supplier contract management, regulatory audits, change management, team leadership
Preferred skills
QP authorization, audit experience, supplier management
Technologies
GMP Annex 16, EU Directives 2001/83/EC, 2003/94/EC
Responsibilities
Lead and coordinate the QP team, ensure GMP compliance during manufacturing/packaging/testing, supervise batch release for EU/EEA markets, manage quality contracts and audits, review and approve batch documentation, participate in regulatory audits, develop quality systems.
Seniority
Senior, hands-on IC with leadership responsibilities
