Quality Systems and Validation Manager

Company
Defence Science & Technology Laboratory
Date Posted
25th September 2018
Reference
CRA1JP00029747
Sector
Public Services and Administration, Science and Pharmaceuticals
Location
Porton Down
Benefits
In Scope
Salary
£450 to £550 Per Day

Analysing data; Completing validation protocols and validation plan summary reports; Participating on various project teams; Developing project plans/schedules for commissioning and qualification deliverables associated with a project or process.

  • Author/Review/Approve validation deliverables.
  • Design and manage Validation Master Plan strategies
  • Provide CSV oversight to IT programmes assuring compliance in-line with but not limited to: FDA, MHRA, GxP and Dstl standards.
  • Ensure that 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 proactively 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
  • Work around change controls
  • Attend governance, progress and review meetings when requested by the project team(s).

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