Public Services and Administration, Science and Pharmaceuticals
£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).