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SUMMARY

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 LAF or CDSC 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.

The QP is responsible :

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 comply with procedures and the principles of GMP
Supporting / Liaising with the Batch releasers responsible for product release
Supporting / Liaising with Dispatch and customer service to manage quality issues and timely customer service
Supporting the preparation of Deviation and QA trend reports
Supporting the preparation of Key Performance Indicators (KPIs)
Supporting investigation of customer complaints / 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 coordination and performance of corrective and preventive action investigations (CAPA’s)
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 to 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 (CAPA’s)

Batch Disposition:

Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and supports production.
Support / 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
Supporting / 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

Changes/New projects/Periodic reviews:
Support the introduction of new products
To review and approve qualification/verification protocols/reports, procedures, specification, 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 to promote continuous improvement. Identify and implement continuous improvement opportunities.
Ensure that change controls are compliant with applicable procedures and that it does not inadvertently alter the validated state of a process/product.
Compiles quality impact assessments and quality approval of change control phases.

Customer Complaints

Awareness of complaint and quality defect investigations.
Utilize both Global and local systems for management, investigation and reporting of customer complaints.
Ensure all complaints are closed within specified timeframes.

Inspection/Audit

Ensure inspection readiness in work completed.
Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring 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
Providing back up on control and issue of Quality Documentation
Implementation, execution and administration of non-conformances
Complete additional Quality related tasks and assignments as required by the department manager
Compliance to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) or Good Distribution Practices (GDP), as applicable
Review of process change controls
Training of Quality and Manufacturing personnel
Provide support in other Quality roles as needed.
Compliance to Environmental Health & Safety (EHS) requirements

EDUCATION AND/OR EXPERIENCE

QP Qualification
Pharmacy Degree (or equivalent) in science-related discipline essential
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 ability to manage a wide range of specific tasks
Good organizational, coordination and communication skills
Flexible Highly
Motivated
Team Player

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

Job Description