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Baxter Logo Baxter · Quality Control

Qualified Person

Ireland, Dublin Employment contract · 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.

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
  • Ensuring 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
  • Investigate customer complaints/quality defects
  • Coordination and performance of corrective and preventive action investigations (CAPAs)
  • Ensure operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and support production
  • Support and liaise with the Batch releasers responsible for product release
  • Responsible for reviewing production and batch records for completeness and releasing product
  • Perform quality review of orders prior to manufacture
  • QA approval of environmental monitoring results and trends
  • Support introduction of new products
  • Review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations, and project validation/plans
  • Support timely release of equipment, utilities, facilities, and computer systems following execution of test protocols
  • Provide support in other Quality roles as needed

Requirements

  • Pharmacy Degree (or equivalent experience) in a science-related field
  • QP Qualification
  • 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

What we offer

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