Contract Computer Systems Validation Analyst

Mid Glamorgan
Up to £500/day
24 Nov 2016
22 Dec 2016
Contract Type
Full Time

Job Elements: -

• Provide guidance regarding the identification and resolution of any gaps identified in IT’s Quality Management System and FDA expectations
• Undertake such corrective actions as may be defined by the project manager. This may include but not limited to: -

o Identifying and creating missing Policies, SOPs and work instructions
o Updating existing documents to bring them into line with regulatory requirements
o Identifying and rectifying weaknesses in data integrity processes and procedures
o Ensuring that all relevant project and system related documentation conform with FDA expectations
o Advise staff regarding the ongoing maintenance of the Quality Management System and project documentation requirements

The ideal candidate will have:

• You will have a degree, or diploma, in a relevant field and 3 years’ experience of Computer Systems Validation in the pharmaceutical industry.
• Knowledge of GxP, GAMP and regulatory guidelines is essential.
• Ability to communicate at all levels is required.
• Experience of working within cross-functional teams is essential.
• Experience of regulatory inspections is desirable.

Apply for Contract Computer Systems Validation Analyst

Already uploaded your CV? Sign in to apply instantly

All answers are required


Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB

4000 characters left

By applying for a job listed on you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.