• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • QA Technical Specialist – Co. Waterford

    Role Summary:


    • Our client is looking for a QA Technical Specialist to join their busy bio-pharmaceutical state-of-the-art facility in Co. Waterford.
    • The QA Technical Specialist reports to the QA Manager providing leadership, knowledge and expertise and hands on support for the introduction of a new MES system at the site in Co. Waterford.
    • The position works closely with Operations & MES functions to design, install, evaluate and qualify a MES system fit for use.


    Core Duties and Responsibilities:


    • Perform the QA representative role in the development and implementation process of Manufacturing Execution System (MES) project.
    • Review of MES documentation, recipes and process flows; supporting MES change control
    • Complete the QA oversight to ensure the design and validation of the MES system meets cGxP, data integrity and site requirements
    • Review and approval of MES validation documents
    • Authoring, Review and Approval of cGMP Documentation associated with the MES project
    • Act in a lead capacity providing quality support to a MES project working with other functions to deliver project on time and in compliance
    • Support the development and implementation of Master Batch Records and procedures for existing product platforms (e.g. Auto Injector).
    • Support the project team with defining strategies for change controls, risk assessments and UAT testing documentation
    • Perform timely review of documentation / process maps / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
    • Liaising with both internal and external customers on quality issues.
    • Participate in the preparation and review of procedures and batch documentation.
    • Preparing and supporting MES systems for batch release.
    • Provide training support to site TMs on quality related aspects of MBR process and actively participate in change management activities
    • Working as part of a project team on site ensuring products are manufactured, in accordance with cGMP.
    • Ensure that all work carried out is in compliance with the required standards conforming to company, cGMPs, cGLPs, SOPs, regulatory regulations and guidelines.
    • Review and approval of deviation, CAPA’s, quality events, change controls and tasks.
    • Acts as Quality Point person providing guidance / feedback on quality issues/concerns.
    • Analysing, identifying and implementing quality and operations process improvements which will improve process capability and performance.
    • Actively contribute to continuous improvement initiatives.
    • Conduct duties in a safe manner and report all safety issues or concerns.


    Minimum Qualifications and Experience:


    • This is an experienced QA role with requirements of batch review and EBR experience.
    • Knowledge of Change Control process and QA projects essential.
    • Third Level Degree in Sciences or Engineering discipline.
    • No shift required for this role
    • Detailed knowledge of cGMP pharmaceutical environment.
    • Exemplary communication, dedication and keen focus on delivering key to success within the role.


    To Apply: Quote – PE22117


    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.