• 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
  • Compliance Specialist – Dublin

    Role Purpose:


    • We are recruiting an Inspection Readiness, Senior Specialist (Compliance) contract position to join an existing Quality team on site.




    • Support the implementation of the Inspection Readiness Program on-site.
    • Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
    • Lead proactive evaluation of site compliance against emerging regulatory trends.
    • Be an advocate of continuous improvement in the Quality Management Systems.
    • Initiate and maintain Quality related metrics related to the Site Inspection Readiness program, ensuring effective communication and follow up of same.
    • Lead and perform internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
    • Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
    • Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
    • Generate and report metrics / trends for program adherence to requirements and effectiveness.


    Education & Qualifications Required:


    •  Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
    • This role requires a seasoned QA Senior Specialist with a minimum of 8 years’ experience in a similar Compliance-related role in the Biopharmceutical industry.
    • A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends.
    • Must have at least 3 years’ experience in delivering Inspection Readiness Programs and Internal Audit programs in a pharma/biotech regulated environment.  Experience working in a drug substance manufacturing environment is highly desirable.
    • The motivation to be an inspiring member of a high performing team.
    • Communication, decision making, people influencing, and project management skills will be important.
    • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
    • GMP Inspection Readiness & Audit experience in the Pharmaceutical industry
    • Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues
    • The desire to continuously learn, improve and develop



    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

    Click here to submit your CV

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