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CSV Consultant

  1. North East
  1. Contract
  1. Life Sciences
Date Posted04 Sep 2020
Computer Systems Validation (CSV) contract opportunity, to join a world leading pharmaceutical organisation near Newcastle.

The successful candidate will join the site QA IT team to provide independent oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. 
The QA IT specialist will support routine and project CSV activities, including upgrades of existing process control and laboratory systems.

  • Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems.
  • Providing independent quality review and approval of system changes.
  • Supporting and approving computerised systems investigations and deviations.
  • Ensuring consistent approach to qualification, change and deviation management across systems and projects.
  • Managing and prioritising day-to-day activities through active alignment with the assigned projects and business areas, and supporting other areas as needed.
  • Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
  • Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.
  • Experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Expert knowledge of relevant regulations and industry standards.
  • Project management experience will be an advantage.
  • PCS and PAS-X experience will be an advantage.

To apply or for further information get in touch today!

The candidate must have the rights to work in the location stated in the job advert.

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