Senior Manager, Eu Qualified Person Commercial Products
BeiGene
Remote
Eu gmp annex 16
Manufacturing and import authorization
Quality management system
The Qualified Person (QP) Commercial Products is responsible for ensuring that each finished medicinal product batch has been manufactured and shipped in accordance with GMP, the terms of the MIA, the MA or made for export as per European Directive 2001/83/EC
Job Summary
The Qualified Person (QP) Commercial Products is responsible for ensuring that each finished medicinal product batch has been manufactured and shipped in accordance with GMP, the terms of the MIA, the MA or made for export as per European Directive 2001/83/EC.
The incumbent will report to the Director, Distribution & Regional Quality, Europe Commercial Quality Head and ideally also qualifies as a Responsible Person GDP.
The QP carries out his/her direct supervision of activities according to the establishment license and has the decision power to take any action which is necessary to ensure compliance with the legal requirements.
Matching Summary
The Qualified Person (QP) Commercial Products is responsible for ensuring that each finished medicinal product batch has been manufactured and shipped in accordance with GMP, the terms of the MIA, the MA or made for export as per European Directive 2001/83/EC.
Skills & Requirements
Must-have
EU GMP Annex 16
Manufacturing and Import Authorization
Quality Management System
European Directive 2001/83/EC
batch certification
GMP compliance
Nice-to-have
Collaborative Spirit
Driving Excellence
Bold Ingenuity
Patients First
sense of urgency
sensitive for the needs of the organization
Key Requirements
Pharmacist/MSc or Scientist recognized by Regulatory Authority
3 years of experience in healthcare/pharmaceutical/biotechnology
Experience as a QP in pharmaceutical or biotech industry