Computer Systems Validation Specialist

Uniting Ambition Limited
£450 - 480 per day
07 Oct 2017
08 Nov 2017
Contract Type
Full Time
Computer Systems Validation Specialist Berkshire 12 months Our client is a true global leader with operations in over 60 countries worldwide, over 35,000 employees with a multi-billion pound turnover. With continued growth, they are seeking a CSV Specialist who will be responsible for the management of their validation during a global piece of work in a fast-paced environment. Responsibilities / Accountabilities IS Compliance and Validation - Author, review, approve validation deliverables. - Design and manage Validation Master Plan strategies for Global Level Programmes - Provide CSV oversight to IT programmes assuring compliance in-line with but not limited to: FDA, MHRA, GxP and company standards. - Ensure that global and local standards regarding Computer Systems Validation are implemented and adhered to. - Work with business users and IT staff to identify and scope validation related processes. - Identify compliance risks (with respect to Pharmaceutical industry regulations impacting computer systems) and pro-actively work with the business and IS to address these - Provide leadership to ensure that computer systems validation activities are implemented consistently across applicable programmes - Coaching, Guidance and Assurance to project teams on computer systems validation deliverables - Influence and enforce Good Documentation Practice standards Professional Qualifications/ Experience Qualifications - - Extensive experience in Healthcare/Pharmaceutical business processes including FDA/MHRA approved and validated systems environments. - Extensive experience of dealing with 21 CFR Part 210, 211, 820 and 21 CFR Part 11 and DEA regulations. - Extensive experience in CSV methodology and GAMP standards. Experience - - Excellent Computer Systems Validation skills - Support to Global IT programmes - Design and Manage Validation activities for Global Level Programmes - Attention to detail when reviewing documentation - Excellent written and oral communication skills - Good organisational skills - Working within regulated industries such as pharmaceutical/healthcare companies - Up-to-date knowledge of GxP Regulations, industry trends, inspection findings etc. CSV / GxP / GAMP / Validation / Compliance / Healthcare
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