Qualified Person

Summary

The Baxter Healthcare Ltd Compounding Facility in Dublin operates under a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). The Qualified Person (QP) is primarily responsible for the release of Nutrition, Chemo and Antibiotic products and provides oversight and quality assurance for 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. The QP ensures all products released comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation, and Baxter Healthcare Ltd Standards. The QP must undertake the necessary training prior to application for inclusion on the Dublin Compounding Facility (DCF) Manufacturing Licence.

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
• Become eligible for inclusion on the Manufacturing License as a Qualified Person
• Ensure products and processes comply with procedures and the principles of GMP
• Support / Liaise with the Batch releasers responsible for product release
• Support / Liaise with Dispatch and customer service to manage quality issues and timely customer service
• Support the preparation of Deviation and QA trend reports
• Support the preparation of Key Performance Indicators (KPIs)
• Support 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
• Support and coordinate the performance of corrective and preventive action investigations (CAPA's)
• Review process change controls
• Review validation protocols and reports
• Provide support to the site wide Quality Department
• Assist in the internal and external audit program and participate in regulatory and corporate/internal audits, and perform supplier audits (as required)
• Performance and supervision of recall assessment
• 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 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.
• Support / 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
• Supporting / Liaise 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 maintain stability data on the system when required and in accordance with the annual stability review schedule.
• Changes/New projects/Periodic reviews: Support the introduction of new products; 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; Carry out 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 backup 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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