• 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
  • Quality Specialist – Microbiology – Co. Carlow

    Role Summary:

     

    • A vacancy has arisen for an experienced Quality Specialist (Microbiology) at our client’s pharmaceutical site in Co. Carlow.
    • Reporting to the Microbiology Laboratory Coach the successful candidate will provide in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company’s priorities of: Compliance, Supply, Strategy and Profit Plan.
    • This role is responsible for all aspects of method and equipment validation in the microbiology department assisting in the effective and efficient running of the method and equipment validation programs.
    • In addition, providing on-going technical support to the site in the area of microbiology and contamination control.
    • The ideal candidate will demonstrate a high level of leadership, collaboration, and coaching to facilitate the team in becoming a high-performance organization.
    • Central to this objective will be the active engagement and communication with all internal (e.g. QC Analytical, Tech Ops, IPT, QA) and external (e.g. Microbiology COE) stakeholders.
    • A high level of innovation, enthusiasm and drive will be required to deliver technical excellence in analytical microbiology related methods.

     

    Core Duties and Responsibilities:

     

    • Technical support and provision of technical leadership in microbiology to other area personnel.
    • Development of Microbiological methods, Method Validation and Method Qualification, mainly bioburden, endotoxin and Sterility test methods.
    • Analytical Method Transfer and Qualification
    • Approval of procedures, protocols, reports and other GMP documents as required
    • Performance, design and direction of bench experiments for validation purposes
    • Troubleshooting of issues which arise during the execution of validation studies and routine tests.
    • Microbiology Support to Site Investigations and Participation in Specifications Development as required
    • Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
    • Laboratory Equipment Qualification / Risk Reduction
    • Procedural updates & General Analytical Support to Quality Control Laboratories
    • Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
    • Troubleshooting of suspected Microbiological Contamination events.
    • Acts as a resource to colleagues with less experience in Microbiology
    • Leads analytical microbiology project improvement teams and coaches and guides colleagues within the site and also in the network on analytical microbiology.
    • Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
    • Assessing compendial and regulatory updates in regards to the area of Microbiology and Laboratories.
    • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
    • Makes decisions within guidelines and policies which impact microbiology projects.
    • Liaises with the global Microbiology Network to ensure alignment on actions related to the relevant Quality bulletin/QMS and regulatory changes.
    • Works with sister and other sites to aid them in Microbiology related topics, as required.
    • Ensure highest safety standards.
    • May be required to perform other duties as assigned

     

    Minimum Qualifications and Experience:

     

    • Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
    • Demonstrated change management skills (CEM) with continuous improvement.
    • Demonstrated knowledge in microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.
    • The ideal candidate will have at least 7 years’ experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 3 years’ experience in a Microbiology function.
    • Knowledge and experience in interpreting current applicable regulatory requirements and providing independent support to the site
    • Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance
    • Demonstrated ability to drive the completion of tasks, with excellent planning and scheduling skills as well as use Leadership Behaviours.
    • Demonstrated delivery of SME knowledge above site
    • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.
    • Advanced PC skills such as Excel, Word, PowerPoint
    • Demonstrated ability to clarify, communicate and solve complex problems, with effective time management and multi-tasking skills.
    • Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application.

     

    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.