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Qp & Quality Manager Compounding

https://www.baxter.com/ Logo

Baxter

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Location:
Ireland , Dublin

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Contract Type:
Not provided

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Salary:

Not provided

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. You will play a crucial role in maintaining top quality and compliance in our manufacturing processes. This outstanding opportunity lets you work in a dynamic environment passionate about innovation and excellence. You will lead efforts to ensure our compounded sterile preparations meet strict European Legislation and Baxter Healthcare Ltd Standards.

Job Responsibility:

  • Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4
  • 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 to minimize product and process risks
  • Coordinate the management, execution, and approval of quality documents and records for the site

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
  • Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
  • Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
  • Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions
What we offer:
  • Pension
  • Competitive package
  • 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

Additional Information:

Job Posted:
April 11, 2026

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