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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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Qualified Person

Benefits

Job Description