• 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
  • Software Quality Lead – Co. Kilkenny

    Role Purpose:


    • A fantastic opportunity has arisen for a Software Quality Lead to support the development and onward growth of our client’s new manufacturing facility and to join their team in Co. Kilkenny.
    • For this role it will be a very big advantage if you can bring experience in developing projects or sites from square one.
    • The successful candidate will be leading a small specialist team and will contribute towards ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance through the effective oversight and management of Software Quality Lead.
    • The Software Quality Lead will take responsibility of implementing Quality objectives and ensuring short term and long term quality goals are met.


    Core Duties and Responsibilities:


    • Assist in the development & implementation of software systems & policy compliance to regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
    • CSV subject matter expert to ensure compliance with GMP, and Data Integrity requirements on all systems.
    • Lead the team responsible for the validation and verification of computerised systems
    • Collaborate and support digital and data analytics projects.
    • Communicate clearly to stakeholders regarding active risk management and problem solving
    • Champion training and development of team.
    • Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
    • Experience, and understanding of Software Change Control
    • Analyse quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
    • Develop key metrics/indicators to track performance and compliance and analyse data to develop and implement improvements.
    • Analyse and implement corrective action in relation to non-conformance


    Education & Qualifications Required:


    • 3rd Level Degree in an Engineering, Computer Systems or Science discipline.
    • A minimum of 5 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles, and leading on quality software projects ideally in Medical Device or Pharmaceutical manufacturing
    • Proficient Microsoft office suite
    • Strong problem solving and analysis skills
    • Proven presentation experience


    To Apply: Quote – PE23051


    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, R95 F727, Ireland.
    +353 56 77 90100

    Click here to submit your CV

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