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Qualified Person

Ireland, Dublin · Job Posted May 30, 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
  • To complete any other activities as directed by Quality management

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
  • Working in a project-based environment
  • Previous experience as a batch releaser

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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  • Pharmacy Degree (or equivalent experience) in a science-related field is required
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  • 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
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This is where you make a difference in our patients’ safety. As a member of the ...
Location
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Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
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  • Working in a project-based environment would be advantageous
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  • Previous experience in an aseptic manufacturing facility
  • Previous experience as a batch releaser would be advantageous
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  • 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
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