Quality Assurance Specialist

Dublin, Dublin North
07 Mar 2023
31 Mar 2023
Louise Catherine Kelly
Job Type


Quality Assurance Specialist.

  • Manage and maintain existing GDP (Good Distribution Practices) and GMP (Good Manufacturing Practices) structures associated with Wholesale Distribution Authorisation Licence.
  • Support validation activities, including mapping studies and protocol execution.
  • Develop, enhance and maintain the companies Quality Assurance Program, to meet the Best in Class standards.
  • Engage proactively with competent authorities and regulatory bodies in order to maintain legislative compliance and establish key performance indicators as required e.g. HPRA, BRCGS, ISO.
  • Identify and implement training to ensure proper and efficient completion of all quality functions.
  • Use continuous improvement tools to instigate actions for improvements.
  • Be the representative for the company, and customer contact on all quality related queries, compliance requests, audits & follow up, customer complaints, quality agreements, and technical agreements.
  • Conduct internal audits/self-inspections according to the Annual Audit Schedule.
  • Promote the corporate quality culture within McArdle Skeath, promote awareness and reinforce understanding of quality processes and policies, facilitating compliance.
  • Manage the Health & Safety, Environmental & Security Policy within the Quality System.
  • Maintain compliance and report on temperature monitoring and engage with suppliers of quality related services.
  • Champion CAPA requirements of the organisation and proactively engage all stakeholders
  • Problem solve using a defined problem solving technique & detailed Root Cause Analysis to ensure timely completion of all corrective actions
  • Provide engineering support to operations ensuring consistent application of quality techniques.
  • Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources.


  • Experience in a Quality role within a science/healthcare/ Biopharmaceutical/logistics/food industry/manufacturing.
  • Experience in validation / mapping study activities and associated documentation.
  • Experience of development, implementation and management of Quality Assurance Systems.
  • A working knowledge of using Lean Tools for Continuous Improvement and Waste Elimination
  • Good communication, reporting, presentation and analytical skills
  • Good interpersonal skills appropriate to all levels in McArdle Skeath as well as Clients, Suppliers and Competent Authorities
  • Relevant Batchelor of Science degree or equivalent.
  • Internal audit training.

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