IT QA Specialist/Denmark/€100+/Start ASAP

Next Ventures is urgently looking for an IT QA Specialist/Denmark/€100+/Start ASAP

Oversee that the customers IT QMS are followed. Furthermore that validation process and requirements are in accordance with cGxP.

Responsibility:
Ensure that the GxP requirements for the validation are specified correctly and in accordance with cGxP. Furthermore require and review justifications for scope of works undertaken by a risk based approached. Review of the justification must address GxP aspects as well as ensuring a quality outcome of the involved activity.

Authorisation of documents applicable for QA signoff.
Report on compliance activities to compliance lead.
Take lead on specific compliance activities.

Overseeing the GxP compliance aspects when validating the SAP platform together with the compliance team and the system owner representative. Dialogue and control of the change process with Line of Business (LOB).
Focus/Performs:
Validation of the solution and authorisation of the documents.
General Capabilities:
The person must have extensive experience with computer systems validation, cGxP and cGAMP. Furthermore have experience with SAP system validation and quality assurance is a must.

Key criteria's to be meet:

Extensive experience with computer validation in accordance with cGAMP.
Excellent skills in written and verbal English.
Experienced in the role as IT QA Specialist - minimum 5+ years
Knowledge about pharmaceutical production and related QMS(s) - minimum 10+ years

Secondly:
Good communication skills and dynamic approach.
A team player
Independent and with a good drive.
Firm compliance attitude, however with a pragmatic approach.

Start: ASAP
Duration: 30st June, 2015
Location: Copenhagen
Work load: 100 %
Working language: English

If you feel this role could be of interest then could you please send your CV and we will call you back TODAY to discuss further with a view to securing an interview as soon as possible. We look forward to hearing from you.