• 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
  • Associate Quality Specialist – Co. Tipperary

    Role Summary:


    • A new opportunity has arisen for a Associate Quality Specialist to join our client’s pharmaceutical site in Co. Tipperary.
    • The successful candidate supports day to day QA activities in the facility.
    • The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).


    Core Duties and Responsibilities:


    • Participate as functional expert in the cross functional team that manages production right first time on site.
    • Review and approve batch, cleaning and testing documentation.
    • Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
    • Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
    • Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
    • Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
    • Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
    • Ensure changes controls raised are documented, assessed and completed.
    • Prepare Annual Process and System Reviews.
    • Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
    • Participate in the generation and communication of quality metrics.
    • Creation, review and approval of quality procedures as required.


    Minimum Qualifications and Experience:


    • Degree or post-graduate qualification in Science, Pharmacy or equivalent.
    • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
    • Spray drying experience desirable.
    • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
    • Experience and knowledge of GMP Requirements for Electronic /paper free operations.
    • Experience in High potency manufacturing desirable.
    • Excellent written and oral communication skills. Organizes and delivers information appropriately.
    • Interacts with people effectively. Able and willing to share and receive information.
    • Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.


    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.