Beschreibung
QA CAPA/Deviations - Project SupportDuration: 12 months
Start Date: December 2014
Location: near Düsseldorf, Germany
Our biotech client is currently undergoing a rapid expansion and growth phase. They require extra support to execute and manage CAPAs/Deviations from day to day business as well as ongoing project work. The successful candidate will be working in the engineering projects team bringing QA GMP and FDA expertise.
The Responsibilities
The main task will be to manage, oversee and execute CAPAs and deviation investigations including relevant documentation to completion and final sign off.
The CAPAs and Deviations will cover:
Clean Utilities
Process Engineering
Calibration and Maintenance
Working with the project team to review validation and commissioning documentation for the site expansion projects.
Requirements
Experience of overseeing and execution of CAPA and deviation investigations full life cycle.
Experience working in a pharmaceutical environment essential, ideally biotech.
Experience with deviations from utilities, process engineering and calibration & maintenance desired.
Extensive knowledge of GMP and FDA requirements.
Previous experience of working as part of a CAPEX project team or in a projects environment required.
Fluent or mother tongue German language skills