Description
For our customer we are looking for an IT QA Specialist.
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
Please, apply directly through our system with
- your updated CV
- all inclusive hourly price
- 2 references (people)
- information on when you are available to start
In addition, please describe why you would be the most suitable candidate for this position (in the motivation field.)
We would like to thank you in advance for your application. However, due to a resource issue, we would like to inform you, that only the most relevant candidates will be contacted by us and get feedback.