QP &Quality Manager Compounding Sandyford

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Join Baxter Healthcare Corporation as a QP & Quality Manager Compounding in Sandyford. 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.

If you thrive in an ambitious setting and are driven by a mission to save and sustain lives quickly and simply, we want to hear from you. Join a team that works with courage and collaboration to deliver world-class healthcare solutions.

Essential Duties and Responsibilities

• Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use. This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union." Follow Commission Directive 2003/94/EEC, its amendments, and any Baxter company requirements.
• Act as a Qualified Person (QP) responsible for implementing the quality management system. Lead all aspects of the compounded products release process. Ensure strict adherence to regulatory and customer requirements.
• 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.
• Support facility projects passionate about process development and quality improvement initiatives.
• Foster a culture of quality awareness and dedication among all site staff, promoting and implementing a robust quality culture.
• Establish quality goals for the site in accordance with Baxter's business strategy.
• Manage local quality resources, evaluating their performance against site and personal objectives, and provide necessary training and development.
• Stay abreast of regulatory, mentorship, and legislative updates relevant to the site, ensuring continuous professional status and standards are maintained.

“What are some of our benefits of working at Baxter?

• Pension
• Health Insurance
• Life Assurance and much more.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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