• 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 Documentation Controller – Dublin

    Role Summary:

     

    • This role will be responsible for supporting the Quality Systems Department in the management of the site GMP documentation, and in supporting the Quality Assurance functions in various administrative duties.
    • Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers

     

    Core Duties and Responsibilities:

     

    • Responsible for the control, operation and maintenance of the site Central Documentation Control system
    • Be a document system expert; this will include document generation, review, approval and document system work flow expedition e.g. SOP’s, Work Instructions, Reports
    • Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
    • Support site activities through documentation generation, filing, tracking, auditing and maintenance of associated databases.
    • Maintain the site archiving area, logging in new documents and logging out documents as requested following site procedures and practices
    • 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.
    • General audit preparation of documentation for audits (i.e. FDA, IMB, Corporate, Customer, etc)
    • Presentation, compilation and review of data as directed

     

    Minimum Qualifications and Experience:

     

    • 2+ years experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
    • Supervisory experience preferable
    • Knowledge of EU/US quality related pharmaceutical regulations
    • Degree in Science or related discipline preferable

     

    To Apply:

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

    recruitment@prochem.ie

    Click here to submit your CV

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