Werde Teil unseres Talentpools für zukünftige Qualified Persons (QPs) / Sachkundige Personen (all genders)
Core
Central role in pharmaceutical quality assurance, responsible for batch release and certification of medical products in R&D or Operations.
Role type
Qualified Person (QP) / Sachkundige Person
Builds
Medical products (Drug Product / Finished Goods) and clinical trial preparations
Domain
Pharmaceutical industry / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Licensed pharmacist (Apotheker), QP certification (15 AMG, EU GMP), GMP knowledge (D, EU, US), international pharmaceutical law, deviation handling, CAPA definition, contract review (QTAs), project management basics
Preferred skills
Analytical thinking, complex situation analysis, problem-solving, initiative, cross-functional collaboration, network management with external partners
Technologies
GMP documentation systems, regulatory submission tools (IND/IMPD)
Responsibilities
Exercise QP function per legal/regulatory requirements, release and certify AbbVie products, ensure compliance with legal requirements and IND/IMPD submissions, process and approve deviations including root cause analysis, create and review GMP documents and quality contracts, participate in quality assurance contracts with partners
Seniority
Mid-Senior (5+ years experience)