CSV/I.T Validation Manager

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Overview of role; - Ensure global IT organisation is in compliance with all healthcare laws and regulations - with a large focus on CSV - Requires good communication skills with I.T and non I.T staff around the world - Responsible for coordination and facilitation internal and external audits of IT - Work with auditors within regulatory and quality, IT and finance

Responsibilities overview; - 60% providing consultation and governance in the areas of regulatory requirements and CSV/computer systems validation -

20% coordinate and manage global IT efforts toward compliance with Quality system regulations and non product CSV in compliance with FDA CFR 1 part 820/part 210/211 and ISO13485 -

5% work with internal and external auditors to facilitate all IT components of regulatory audits- schedules, providing work spaces, and execution -

5% perform internal and or external audits of IT sites to insure IT CSV procedures and regulations -

10% adhere to all IT policies, procedures and standards Education needed;

Bachelor's degree in a Computer, Science, Engineering or related field, or an equivalent combination of training and experience.

Experience needed; At least 12 years in Information Technology with at least 5 years of that in supporting and/or managing IT Quality Computer System/Software Validation delivery and oversight. Significant experience of Cloud computing in a healthcare environment, computer systems validation

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales