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Validation Consultants
CTG provides services in particular to Life Sciences companies, for example to ensure compliance with regulations so as to safeguard patents. We validate computer systems, qualify IT infrastructure and equipment, and deal with other compliance issues.
For our business unit Regulatory Compliance we are hiring a(n)
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CTG has over 40 years experience in providing IT application management, consulting, software development and integration, and staffing solutions to our Global 2000 clients. We enable our clients to focus on their core businesses and use IT as a competitive advantage to excel in their markets. CTG combines in-depth understanding of our clients' businesses with a full range of integrated services and proprietary ISO 9001:2000-certified service methodologies. We have a network of offices in the USA, Belgium, Luxembourg and the UK
Due to expansion of our UK operations, we will be looking for experienced Computer Systems Validation Engineers/Consultants to join our Regulatory Compliance team in the UK, to work on client projects in 2010.
A typical project will encompass some or all of the following:
To operate/consult at a single site/local network level
To operate/consult at a strategic/enterprise level or on multiple sites
To liaise with corporate IT/user management to develop validation strategy
To conduct legacy/prospective system assessment for GxP/Part 11 compliance assessment/gap analysis and reporting
To conduct a risk management excercise to identify and mitigate regulatory and business risks and to determine the areas on which to focus the validation effort
To provide quality coaching and training in CSV processes
To develop corporate polices relationg to management of infrastructure and networks (e.g. security, validation/qualification, 21CFR part 11 interpretation, change management, business continuity, training policy)
To create a corporate Validation Master Plan
To review and report validation outcomes
To undertake an inspection readiness audit
To be successful in the role you will need to have a combination of the following:
A working knowledge of 1 or more validation methodologies
A working knowledge of 21 CFR Part 11
Understand the principles of Infrastructure Assessment/Gap analysis and Qualification
Expertise in GxP
3-5 years application implementation experience
Ideally some experience within a consultancy role or at least and understanding of consultant-client relationship
The flexibilty to travel and stay away from home during the week is key to this role, as projects could be based anywhere in the UK and may require some travel to Europe
We offer base salary plus car allowance and an attractive benefits package including incentive bonus, private medical and pension.