Computer Systems Validation Specialist

Uniting Ambition Limited
£450 - 480 per day
08 Nov 2017
16 Nov 2017
Contract Type
Full Time

Computer Systems Validation Specialist


6 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
  • Review IS system Change Controls, Incidents and Problems from a compliance perspective
  • Conduct periodic reviews of computer systems

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 / TrackWise / Change Controls

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