Beschreibung
Freelance Audit and Inspection Coordination Support - well-known pharmaceutical company - Hesse, Germany - 4 months plus possible extensionThe role:
The Audit and Inspection Coordination Support is responsible for the management of all drug safety-related activities concerning Regulatory Authority inspections and audits carried out by internal Quality Assurance departments or by external parties, as well as their resolution and follow-up.
This includes:
- 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 to 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
Frame conditions:
Start date: 01.12.2016
End date: 31.03.2017
Option to extend: until end of June 2017
Utilization per Week (Number of Days): 5
On-site Support (in Percentage): 100% Remote Support (in Percentage): 0%
GMP and/or GVP experience min. 5 years
Inspection and Audit experience min. 5 years
worldwide pharmacovigilance legislation exp nice to have
Medical or scientific background min. 6 years
English business fluent
German business fluent
If you are interested do not hesitate to contact me with your english profile!
Marcel Otto
Recruitment Consultant Pharma / Medical Devices / Contract Division
Real Life Sciences
Ein Geschäftszweig der SThree GmbH
Goetheplatz 5-11
60313 Frankfurt
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