• 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
  • QC Documentation Administration Specialist – Co. Dublin

    Role Summary:

     

    • A new opportunity has arisen for a QC Documentation/Administration Specialist at our client’s pharmaceutical site in Co. Dublin.
    • The successful candidate will be responsible for supporting the Quality Control Department in the management of department documentation, and support of the QC functions through various administrative duties.
    • The individual will ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to their customers.

     

    Core Duties and Responsibilities:

     

    • Supporting the management of QC documentation including archival of executed protocols, true copy of executed protocols/reports/documents, authoring/updating QC SOP’s and data compilation/review and data verification as directed
    • Support for preparation of trend reports
    • Coordination and management of QC eLogs
    • Support for 5S, housekeeping and audit readiness for QC Labs
    • Placing purchase orders for non VMI QC lab reagents and coordination/payment of associated invoices
    • Management of purchase orders and associated activities related to budgets and expense reporting
    • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
    • Responds to non-standard requests from customer needs.
    • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
    • Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
    • Lead daily tier meetings, and coordinate bi-weekly departmental updates
    • Scheduling, coordinating and monitoring appointments for department managers
    • Monitoring of department training due dates in Learning Management System (LMS) and supporting system/training requests.
    • Coordination of QC Training curricula and manage and maintain area curricula builds
    • QC designee for Learning and Development (L&D) site meetings
    • Communicate L&D topics and updates at area weekly tiers/meetings
    • Managing learning plan matrices updates when new learning identified (confirming impacted job roles & assignment) e.g. new SOP/WI resulting in new learning in area/cross functionally.
    • Attend weekly L&D business partner meetings and monthly point of contact site meeting.
    • Share L&D information / updates with QC colleagues
    • Champion site agile, Learner-centric Learning culture

     

    Minimum Qualifications and Experience:

     

    • Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent
    • A minimum of 3-4 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
    • Knowledge of EU/US quality related pharmaceutical regulations
    • Basic computer literacy
    • Strong communication and organisational skills
    • High level of technical aptitude & motivation
    • Demonstrated ability to take initiative and attention to detail
    • Good presentation skills.
    • Excellent knowledge of relevant Quality and GMP Compliance Guidelines

     

    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.