Computer Systems Validation Specialist

Recruiter
Uniting Ambition Limited
Location
Slough
Salary
£450 - 480 per day
Posted
08 Nov 2017
Closes
16 Nov 2017
Contract Type
Contract
Hours
Full Time

Computer Systems Validation Specialist

Berkshire

6 months +

£450-480





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



This job was originally posted as www.jobsite.co.uk/job/959486715