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Baxter Logo Baxter · Quality Control

Qp & Quality Manager Compounding

Ireland, Sandyford Dublin 18 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

  • Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
  • Act as a Qualified Person (QP) responsible for implementing the quality management system
  • Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
  • Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time
  • Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly
  • Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products
  • Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety
  • Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

Requirements

  • 6-10 years’ experience of Quality implementation in Pharma industry
  • Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
  • Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
  • Proven leadership experience with a track record of consistently meeting results
  • Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
  • Proven ability to manage/supervise a large and diverse team of employees

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Pension
  • Competitive package
  • Health Insurance
  • Life Assurance and much more
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  • 6-10 years’ experience of Quality implementation in Pharma industry
  • Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
  • Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
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  • Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
  • Act as a Qualified Person (QP) responsible for implementing the quality management system
  • Lead all aspects of the compounded products release process
  • Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
  • Develop and maintain an internal review process to ensure continuous compliance
  • Lead and manage the audit process for the facility
  • Measure and analyze site quality metrics and indicators
  • Develop and implement risk management strategies
  • Coordinate the management, execution, and approval of quality documents and records
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This is where you make a difference in our patients’ safety. As a member of the ...
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Salary:
Not provided
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Expiration Date
Until further notice
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Requirements
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  • 6-10 years’ experience of Quality implementation in Pharma industry
  • Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
  • Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
  • Proven leadership experience with a track record of consistently meeting results
  • Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
  • Proven ability to manage/supervise a large and diverse team of employees
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Job Responsibility
  • Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4 and Commission Directive 2003/94/EEC
  • Act as a Qualified Person (QP) responsible for implementing the quality management system and lead all aspects of the compounded products release process
  • Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and product quality issues
  • Develop and maintain an internal review process to ensure continuous compliance
  • Lead and manage the audit process for the facility
  • Measure and analyze site quality metrics and implement data-driven actions for continuous improvement
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  • Coordinate the management, execution, and approval of quality documents and records including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports
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  • Competitive package
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  • Life Assurance and much more
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  • Paid Time Off
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  • 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
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  • Liaising with Dispatch and customer service to manage quality issues and timely customer service
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  • Facilitating, reviewing, updating, and maintaining stability data on the system when required and in accordance with the annual stability review schedule
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  • Pension
  • Health Insurance
  • Life Assurance
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
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This is where you make a difference in our patients’ safety. As a member of the ...
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  • Pharmacy degree preferable
  • Previous experience in a pharmaceutical company or equivalent-type role
  • Ideally a minimum of 2 years’ experience in a GMP regulated aseptic environment
  • Experience/qualifications in microbiology/environmental monitoring a distinct advantage
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  • Ensure compliance with cGMP, corporate standards/Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements, and industry standards
  • Batch Disposition
  • Inspection and batch release of compounded products under the supervision of a Qualified Person (QP)
  • Responsible for reviewing production and batch records for completeness and releasing product
  • Liaising with the QPs (qualified persons) responsible for product release
  • Performing quality review of orders prior to manufacture
  • Liaising with Dispatch and customer service to manage quality issues and timely customer service
  • Quality approval of environmental monitoring results and preparation of trends
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  • Facilitating, reviewing, updating, and maintaining stability data on the system when required and in accordance with the annual stability review schedule
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  • Life Assurance
  • Support for Parents
  • Continuing Education/ Professional Development
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  • 2 Days a Year to Volunteer
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Baxter
Expiration Date
Until further notice
Flip Icon
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  • 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
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  • Responding to pharmaceutical queries concerning compounded medicinal products from customers and Baxter’s homecare nurses
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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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  • Support for Parents
  • Continuing Education/ Professional Development
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  • Paid Time Off
  • 2 Days a Year to Volunteer
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This is where you make a difference in our patients’ safety. As a member of the ...
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Salary
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Not provided
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Baxter
Expiration Date
Until further notice
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  • 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
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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
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  • Supporting the investigation of customer complaints and quality defects
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  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance
  • Pension
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  • Support for Parents
  • Continuing Education/Professional Development
  • Employee Health & Well-Being Benefits
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