Sachkundige Person / Qualified Person (m/w/d) Pharma
Core
Responsible for releasing manufactured pharmaceutical products in compliance with legal requirements (§ 14 AMG, Annex 16) and managing GMP documentation.
Role type
Qualified Person (QP) for pharmaceutical manufacturing
Builds
Pharmaceutical products (via careerplan.io/jobs/809043-sachkundige-person-qualified-person-mwd-pharma-at-rottendorf-pharma-gmbh)
Domain
Pharmaceutical industry / Regulatory compliance
Deliverable
physical/clinical work
Required skills
Pharmaceutical law expertise, GMP regulations knowledge, independent decision-making, process improvement, analytical thinking, problem-solving, negotiation-level English
Responsibilities
Release manufactured products, approve GMP-relevant documents (SOPs, PQRs, Change-Control, deviations, complaints, CAPAs), act as contact for GMP/regulatory compliance questions, collaborate with production/packaging/quality control, participate in quality system projects, communicate with customers and authorities, represent QP in inspections and audits
