• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • QA IT Specialist – Co. Meath

    Role Purpose:

     

    • A new opportunity has arisen for a QA IT Specialist Shopfloor Systems to join our client’s busy pharmaceutical site in Co. Meath.
    • The successful candidate will join the QA IT team on a site expansion project to provide independent compliance oversight and support for the implementation of new shopfloor automation systems and modifications to existing site systems.
    • The QA IT specialist will 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 a number of shopfloor system, including DeltaV, PLC/SCADA systems, OSI PI and MES.

     

    Duties:

     

    • 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 test deviations.
    • Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project.
    • Providing timely and pro-active QA IT support and guidance to facilitate project timelines, including close collaboration with the technical and business units.
    • Where required, engaging with QA IT teams from other sites and capital projects to standardise and align approach to computerised systems compliance.

     

    Education & Qualifications Required:

     

    • Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
    • Working 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.
    • DeltaV, PLC/SCADA, OSI PI experience and/or PAS-X experience is essential.

     

    To Apply

     

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.