• 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
  • Manufacturing Compliance lead

    Role Purpose:

    •  Support Manufacturing Manager and Manufacturing TLs by management GMP documentation within the manufacturing areas, as the finite schedule SME in manufacturing and building and reporting manufacturing KPIs.

     

    Duties:

    •  Coordinates the management and tracking of GMP documentation and quality actions within the Manufacturing areas including:
      o Manufacturing Batch records
      o Quality Actions (deviations, CAPA, change controls)
      o Develops KPIs for documentation completion versus schedule and activity RFT criteria
    • Measure and report RFT / trend data and work with departments to resolve recurring issues
    • Maintains the weekly finite schedule (from Supply Chain) and measures daily adherence and updates Supply Chain on batch completion details
    • Updates tier 0 and tier 1 metrics daily, as required, on behalf of manufacturing TLs and/or manager
    • Coordinates preparation of manufacturing presentations for routine forums such as Quality review, S&OP, etc.
    • Attends weekly schedule meeting in lieu of Manufacturing managers for TLs if required
    • Leads preparation activity in manufacturing for internal and external regulatory audits
    • Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
    • Liaise, schedule and support Process Engineering and Facilities works to be carried out and raise work orders and GMP permits as required.

     

    Education & Qualifications Required:

    •  Third level qualification an advantage
    • Minimum of 2 years’ experience in a similar role
    • Experience working in a GMP environment is required
    • Excellent organisational skills
    • Excellent accuracy and attention to detail
    • Excellent interpersonal skills
    • Working knowledge of computer packages

     

    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.