Beschreibung
We are looking for aa
Audit and Inspection Coordination Support Associate (m/f)
Reference: -en
Start: 12/16
Duration: 4 MM+
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Preparation of inspections, involving global and affiliate drug safety processes
- Leading inspection preparation across worldwide Drug Safety functions and ensuring that functions outside Drug Safety are appropriately involved
- Leading and coordinating all pharmacovigilance-related activities in inspections and audits
- Ensuring quality of all pharmacovigilance-related documentation disclosed to inspectors and auditors
- Support Drug Safety affiliate staff before, during and after inspections/audits conducted at affiliates
- Contributing to the maintenance of a CAPA database for GDS oversight of PV related CAPA plans and their status
Your qualifications
- GMP and/or GVP experience
- Inspection and audit experience
- Understanding of current worldwide pharmacovigilance legislation is beneficial
- English and German business fluent
- Medical or scientific background
Skills:
- Auditor