Beschreibung
We have an exclusive opportunity for a Computer System Validation (CSV) manager to manage the Validation and Quality standards for their Laboratory systems (GLP, AAS, FTIR, UV VIS).
The position will also provide the responsibility to project manage the implementation of new laboratory systems.
The role is with a global Pharmaceutical company who have an excellent industry reputation. The position is on a Consultancy basis, onsite in the Frankfurt am Main region. Start date of the project is January 2015 for an initial 6 month period which may be extended, there is a competitive Hourly or Daily rate available for the role, flexi hours may be possible for the position.
- German speaking is important to an intermediate standard
- Validation report writing (IQ/QO/PQ/DM)
- At least 5 years Software Validation experience within FDA, CFR, GAMP 5 and GxP regulated environments required
- Project Management experience of installation of software systems is preferred
- Specialisation within Laboratory validation systems is preferred but by no means essential
We hope that the role will be of interest to you and understand that further information may be required before advancing with an application to the end client. Please feel free to contact me at anytime by: applying via this website or by phone and I will be happy to answer any questions you may have, there is also a detailed job description available on request.
Kind regards,
Michael Kellitt
Job Code: 103015
Key Words:
Validation, computer systems, computer systems validation, CSV, software validation, software validation systems, deutsch, Deutschland, ingenieur, engineer, quality manager, quality management, GLP, laboratory, harmonisation, GAMP, GMP, GxP, CFR 510k, freelance, freelancer, project
Michael Bailey International is acting as an Employment Business in relation to this vacancy.