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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:

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 and leading 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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