Qualified Person

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. 

Summary

The Qualified Person (QP) at the Baxter Healthcare Ltd Compounding Facility in Dublin is responsible for releasing Nutrition, Chemo, and Antibiotic products in accordance with regulatory standards. They provide oversight and quality assurance guidance for the compounding process, ensuring compliance with Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation, and Baxter Healthcare Ltd Standards. Sterile batch and patient-specific products are manufactured in a clean room using LAF or CDSC technology.

The QP must complete training before applying to be a Qualified Person on the DCF Manufacturing Licence in Dublin.

Responsibilities

• 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
• 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
• Development of quality system procedures, controlled documents, and processes
• Review and investigation of deviations and reject/scrap reports, and the implementation of corrective and preventative actions
• Supporting and coordinating the performance of corrective and preventive action investigations (CAPAs)
• Review of process change controls
• Review of validation protocols and reports
• Provide support to the site-wide Quality Department
• Assist in the internal and external audit program. Participation in regulatory and corporate/internal audits and performance of supplier audits (as required)
• Performance and supervision of recall assessment
• Participation in regulatory and corporate/internal audits and performance of supplier audits (as required)
• Training of Quality and Manufacturing personnel
• Compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
• Maintenance of professional status and standards
• To complete any other activities as directed by Quality management

Essential duties and responsibilites

• 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 (CAPAs)

• Batch Disposition:

Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and support production

Support and liaise 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

1. QA approval of environmental monitoring results and trends

Support the introduction of new products

Review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations, and project validation/plans as required

Support the timely release of equipment, utilities, facilities, and computer systems following the execution of test protocols

Key member of Quality Risk Management and Operational Excellence to improve efficiencies and promote continuous improvement. Identify and implement continuous improvement opportunities

Ensure that change controls are aligned with applicable procedures and that they do not unintentionally alter the validated state of a process/product.

Ensure inspection readiness in work completed

Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring the site is always audit-ready. Maintain visibility on Production and Processing floors and perform spot checks on product and documentation

Assist in the internal and external audit program. Participation in regulatory and corporate/internal audits. Conduct audits as per internal audit schedule

Review and approve internal audit reports

• Documentation Management:

Manage and maintain the Documentation System

Review and approval of Quality documentation

• Quality System Management and Review:

Support completion of the Quality Management Review meetings and the Annual Product Quality Review

Ensure outcomes, decisions, and actions of the review are documented

Ensure meeting actions are completed to agreed deadlines

• Other:

Overview of regulatory/guidance and legislative updates relevant to Baxter

Compilation of reports in a timely manner as requested

Provide backup on control and issue of Quality Documentation

Review of process change controls

Training of Quality and Manufacturing personnel

Provide support in other Quality roles as needed

EDUCATION AND/OR EXPERIENCE

• 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

Skills

• Good problem-solving and investigation skills
• Good professional standards, meticulous, and demonstrates good attention to detail
• Ability to work under pressure and meet deadlines
• Highly motivated self-starter and team worker
• Ability to work in a team-based environment and manage a wide range of specific tasks
• Good organizational, coordination, and communication skills
• Flexible
• Highly motivated
• Great Teammate

What are some of the benefits of working at Baxter?

If the above resonates, or you would simply love to learn more about the role, apply today and we would be delighted to speak with you!

“What are some of our benefits

 of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Pension
• Health Insurance
• Life Assurance

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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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