Qualified Person

Description:

Full Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your role at Baxter:

The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). The Qualified Person (QP) is primarily responsible for release of Nutrition, Chemo and Antibiotic products. They should oversight and quality assurance expertise and guidance of the compounding process in line with regulatory standards. Sterile batch and patient specific products are manufactured using isolator and/or LAF technology in a clean room environment. It is the responsibility of the Qualified Person to ensure that all products released from the Dublin Compounding Facility comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.

The Qualified Person (QP) is responsible for undertaking the necessary training prior to application for inclusion as a Qualified Person on the Dublin Compounding Facility (DCF) Manufacturing Licence.

What are your Responsibilities:

• Ensure compliance with cGMP, corporate standards/Baxter Quality Systems, site policies/procedures, regulatory requirements and industry standards.
• Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections and Product Complaints and the use of unlicensed drug components.

• Investigations:

• Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies. Assures completeness in terms of root cause, action taken and CAPA.
• Perform investigation of customer complaints / quality defects
• Coordination and Performance of corrective and preventive action investigations (CAPA’s)

• Batch Disposition:

• Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and supports production.
• Liaising with the Batch releasers responsible for product release.
• Responsible for reviewing production and batch records for completeness and releasing product.
• Perform quality review of orders prior to manufacture
• Liaising with Dispatch and customer service to manage quality issues and timely customer service
• QA approval of environmental monitoring results and trends

• Merlin manufacturing system and Stability:
  • Maintenance of Merlin Component Files, Finished Product Codes and review of drug admixture stability and assignment of shelf-lives

• Facilitate, review, update and maintaining stability data on the system when required and in accordance to the annual stability review schedule.