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Baxter Logo Baxter · Quality Control

Quality Systems Specialist

Ireland, Dublin · Job Posted March 26, 2026
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Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Authorization awarded by the Health Products Regulatory Authority (HPRA). The Quality Systems Specialist is responsible for ensuring that systems and products manufactured in the Dublin Compounding Facility comply with the Manufacturing Authorization, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.

Job Responsibility

  • Ensure the compilation of Quality Management Review process
  • Review and approval of process change controls, SOPs, NCRs and CAPAs
  • Implementation, execution and administration of Change Control System and NCR System
  • Administration of Recall process with the Quality management team
  • Administration/co-ordination of risk assessments
  • Support facility projects including process development and quality improvement initiatives
  • Manage and maintain the Documentation System
  • Manage of site archive, storage, retrieval and destruction processes
  • Review and approval of Quality documentation
  • Supporting all departmental administration systems as required
  • To assist with the collation of information and assist in the preparation of reports in relation to Annual Product reviews
  • To ensure that the systems with a GMP impact are maintained as per written procedures
  • Training of Quality and Manufacturing personnel
  • Train and provide feedback to document/process owners on errors for continuous improvement
  • Ensure inspection readiness in work completed
  • Assist in the internal and external audit program
  • Compile and track internal/corporate audit and regulatory inspection responses
  • Support trending and compilation of investigation/system reports in a timely manner
  • Preparation of Key Performance Indicators (KPIs)
  • To administer and develop the complaints system
  • To monitor the Approved Supplier listing
  • Manage supplier complaints and investigation processes
  • Administration of supplier notification/change processes
  • Support the introduction of new products
  • Key member of Quality Risk Management and Operational Excellence to improve efficiencies
  • Ensure that change controls are compliant with applicable procedures and maintain a validated state
  • Support the implementation of the Operational Excellence Programme on the site
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP)
  • Compliance to Environmental Health & Safety (EHS) requirements
  • Support the site-wide Quality Department

Requirements

  • Degree in Science or related discipline
  • Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
  • Experience in dealing with Regulatory Compliance desired
  • Good problem solving and investigation skills would be beneficial
  • An ability to work in a dynamic, fast-paced and goal driven environment
  • Be self-driven
  • Meticulous in attention to professional standards
  • Respond well to time constraints
  • Good professional standards and demonstrates good attention to detail
  • Ability to work under pressure and meet deadlines
  • Highly motivated self- starter and team worker
  • Ability to work in a team-based environment and ability to manage a wide range of specific tasks
  • Excellent organisational, coordination and communication skills
  • Ability to manage a wide range of specific tasks
  • Very good influencing and interpersonal skills

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance
  • Pension
  • Health Insurance
  • Life Assurance
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