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Baxter Logo Baxter · Quality Control

Qualified Person

Ireland, Dublin · Job Posted May 29, 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 Qualified Person (QP) at the Baxter Healthcare Ltd Compounding Facility in Dublin is responsible for releasing Nutrition, Chemo, and Antibiotic products in accordance with regulatory standards. They provide oversight and quality assurance guidance for the compounding process, ensuring compliance with Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation, and Baxter Healthcare Ltd Standards. Sterile batch and patient-specific products are manufactured in a clean room using LAF or CDSC technology. The QP must complete training before applying to be a Qualified Person on the DCF Manufacturing Licence in Dublin.

Job Responsibility

  • Responding to pharmaceutical queries concerning compounded medicinal products from customers and Baxter’s homecare nurses
  • Support facility projects including process development and quality improvement initiatives
  • Becoming eligible for inclusion on the Manufacturing License as a Qualified Person
  • Ensure products and processes align with procedures and the principles of GMP
  • Supporting and liaising with the Batch releasers responsible for product release
  • Supporting and liaising with Dispatch and customer service to manage quality issues and timely customer service
  • Supporting the preparation of Deviation and QA trend reports
  • Assisting in the development of critical metrics for performance evaluation
  • Supporting the investigation of customer complaints and quality defects
  • Perform quality review of orders prior to manufacture
  • Development of quality system procedures, controlled documents, and processes
  • Review and investigation of deviations and reject/scrap reports, and the implementation of corrective and preventative actions
  • Supporting and coordinating the performance of corrective and preventive action investigations (CAPAs)
  • Review of process change controls
  • Review of validation protocols and reports
  • Provide support to the site-wide Quality Department
  • Assist in the internal and external audit program. Participation in regulatory and corporate/internal audits and performance of supplier audits (as required)
  • Performance and supervision of recall assessment
  • Training of Quality and Manufacturing personnel
  • Compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
  • Maintenance of professional status and standards
  • To complete any other activities as directed by Quality management
  • Ensure compliance with cGMP, corporate standards/Baxter Quality Systems, site policies/procedures, regulatory requirements, and industry standards
  • Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections, and Product Complaints, and the use of unlicensed drug components
  • Investigations
  • Batch Disposition
  • QA approval of environmental monitoring results and trends
  • Support the introduction of new products
  • Review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations, and project validation/plans as required
  • Support the timely release of equipment, utilities, facilities, and computer systems following the execution of test protocols
  • Key member of Quality Risk Management and Operational Excellence to improve efficiencies and promote continuous improvement. Identify and implement continuous improvement opportunities
  • Ensure that change controls are aligned with applicable procedures and that they do not unintentionally alter the validated state of a process/product
  • Ensure inspection readiness in work completed
  • Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring the site is always audit-ready. Maintain visibility on Production and Processing floors and perform spot checks on product and documentation
  • Assist in the internal and external audit program. Participation in regulatory and corporate/internal audits. Conduct audits as per internal audit schedule
  • Review and approve internal audit reports
  • Documentation Management
  • Quality System Management and Review
  • Support completion of the Quality Management Review meetings and the Annual Product Quality Review
  • Ensure outcomes, decisions, and actions of the review are documented
  • Ensure meeting actions are completed to agreed deadlines
  • Overview of regulatory/guidance and legislative updates relevant to Baxter
  • Compilation of reports in a timely manner as requested
  • Provide backup on control and issue of Quality Documentation
  • Review of process change controls
  • Training of Quality and Manufacturing personnel
  • Provide support in other Quality roles as needed

Requirements

  • QP Qualification
  • Pharmacy Degree (or equivalent experience) in a science-related field is required
  • Previous QP experience in a pharmaceutical company or equivalent-type role. Ideally a minimum of two years’ experience in a GMP regulated aseptic environment
  • Experience/qualifications in microbiology/environmental monitoring a distinct advantage
  • Working in a project-based environment would be advantageous
  • Experience of implementing changes and process development
  • Previous experience in an aseptic manufacturing facility
  • Previous experience as a batch releaser would be advantageous
  • Good problem-solving and investigation skills
  • Good professional standards, meticulous, 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 manage a wide range of specific tasks
  • Good organizational, coordination, and communication skills
  • Flexible
  • Highly motivated
  • Great Teammate

Nice to have

  • Experience/qualifications in microbiology/environmental monitoring a distinct advantage
  • Working in a project-based environment would be advantageous
  • Previous experience as a batch releaser would be advantageous

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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