QA IT Specialist - Laboratory Information Management systems

  • Location:

    Northumberland, England

  • Sector:

    IT

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Job ref:

    EHLIMS_1598606096

  • Published:

    about 1 month ago

  • Duration:

    12 Months

  • Start date:

    ASAP

  • Client:

    Undisclosed Company

QA IT Specialist - LIMS (Laboratory Information Management systems)
This is a 12 Month Contract
Based in Northumberland
Paying a day rate of up to £303 Pd


Must have experience with LIMS

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.

Responsibilities:

  • 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:

  • 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
  • Expert knowledge of relevant regulations and industry standards.
  • Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
  • Excellent communication skills.
  • Project management experience will be an advantage.
  • PCS and PAS-X experience will be an advantage.

Due to the volume of applications, we regret that we can only respond to those meeting our above requirements.

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