Leitende Qualified Person / Sachkundige Person (§ 14 AMG) (m/w/d)
Core
Lead the Qualified Persons team and ensure GMP-compliant release of patient-specific sterile pharmaceutical products.
Role type
Senior Qualified Person (QP) / Quality Assurance Lead
Builds
Patient-specific sterile pharmaceutical preparations (cytostatics, biologics, ophthalmics, analgesics)
Domain
Pharmaceutical manufacturing (sterile/aseptic) and Quality Management
Required skills
GMP regulations, German pharmaceutical law, Quality Management, regulatory inspections, audit support, team leadership, cross-functional project management, contract negotiation
Preferred skills
Experience in sterile or aseptic manufacturing, experience with cytostatics/biologics/ophthalmics/analgesics, strategic quality system development (via careerplan.io/jobs/2754814-leitende-qualified-person-sachkundige-person-14-amg-mwd-at-abf-pharmazie-gmbh-co-kg)
Technologies
GMP, AMG, AMWHV, Annex 16
Responsibilities
Lead the development of the Qualified Persons team, take responsibility for product release, accompany regulatory inspections and audits, develop the pharmaceutical quality system, lead cross-functional projects, negotiate contracts with pharmacies and service providers, coordinate clinical trial samples
Seniority
Senior, hands-on IC with leadership responsibilities