• 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
  • Instrumentation Specialist – Co. Dublin

    Role Summary:

     

    • A vacancy has arisen for the role of a Quality Control (QC) Instrumentation Systems Specialist at our client’s busy pharmaceutical site in Dublin.
    • The successful candidate will operate as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab.
    • The team working style is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.
    • The Quality Control group ensures all materials used for their products is manufactured, processed, tested, stored, and distributed aligned with their incredibly high standards of quality, meeting all regulatory requirements.
    • Partnering across the internal manufacturing facilities, external contract manufacturers and suppliers they create a global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

     

    Core Duties and Responsibilities:

     

    • The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:
    • Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
    • Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
    • Support the QC department for troubleshooting, investigations, and deviations as an SME.
    • Manage deviations, CAPA’s and change control’s related to the QC and team priorities.
    • Assist with implementation of Quality Chapters to ensure they maintain best practices and build excellence into their QC systems and processes.
    • Author and revise local SOPs, work instructions, and guidelines.
    • Serve as an SME for regulatory and internal inspections and audits.
    • Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.

     

    Minimum Qualifications and Experience:

     

    • Typical Minimum Education: A bachelor’s degree in Engineering, biological science, or related field.
    • Minimum 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
    • Experience in regulatory audits.
    • Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
    • Strong CSV experience with analytical instrument qualification and computer systems implementation.
    • Excellent understanding of data integrity compliance requirements
    • Demonstrated ability to drive complex tasks to completion.
    • Strong organizational, problem-solving, and continuous improvement skill.
    • Ability to prioritize Lab Systems activities in line with the project schedules and business needs.
    • Experience and understanding of the change management requirements of validated systems and software.

     

    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.