Contract Computer Systems Validation Analyst
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.