Qualified Person - 12 Month Ftc

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.
SummaryThe 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.
ResponsibilitiesResponding to pharmaceutical queries concerning compounded medicinal products from customers and Baxter's homecare nursesSupport facility projects including process development and quality improvement initiativesBecoming eligible for inclusion on the Manufacturing License as a Qualified PersonEnsure products and processes align with procedures and the principles of GMPSupporting and liaising with the Batch releasers responsible for product releaseSupporting and liaising with Dispatch and customer service to manage quality issues and timely customer serviceSupporting the preparation of Deviation and QA trend reportsAssisting in the development of critical metrics for performance evaluationSupporting the investigation of customer complaints and quality defectsPerform quality review of orders prior to manufactureDevelopment of quality system procedures, controlled documents, and processesReview and investigation of deviations and reject/scrap reports, and the implementation of corrective and preventative actionsSupporting and coordinating the performance of corrective and preventive action investigations (CAPAs)Review of process change controlsReview of validation protocols and reportsProvide support to the site-wide Quality DepartmentAssist 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 assessmentParticipation in regulatory and corporate/internal audits and performance of supplier audits (as required)Training of Quality and Manufacturing personnelCompliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicableMaintenance of professional status and standardsTo complete any other activities as directed by Quality managementEssential duties and responsibilitesEnsure compliance with cGMP, corporate standards/Baxter Quality Systems, site policies/procedures, regulatory requirements, and industry standardsMaintaining 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 componentsInvestigations: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
1. Perform investigation of customer complaints/quality defectsCoordination 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
1. Support and liaise with the Batch releasers responsible for product release
Responsible for reviewing production and batch records for completeness and releasing product
1. Perform quality review of orders prior to manufacture1. QA approval of environmental monitoring results and trendsSupport the introduction of new products
1. 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
1. 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
1. 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
1. Review and approve internal audit reportsDocumentation Management:Manage and maintain the Documentation System
1. Review and approval of Quality documentationQuality System Management and Review:Support completion of the Quality Management Review meetings and the Annual Product Quality Review
1. 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
1. Compilation of reports in a timely manner as requested
Provide backup on control and issue of Quality Documentation
Review of process change controls
1. Training of Quality and Manufacturing personnelProvide support in other Quality roles as needed
1. Compliance with Environmental Health & Safety (EHS) requirementsEDUCATION AND/OR EXPERIENCE
QP QualificationPharmacy 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 environmentExperience/qualifications in microbiology/environmental monitoring a distinct advantageWorking in a project-based environment would be advantageousExperience of implementing changes and process developmentPrevious experience in an aseptic manufacturing facilityPrevious experience as a batch releaser would be advantageousSkillsGood problem-solving and investigation skillsGood professional standards, meticulous, and demonstrates good attention to detailAbility to work under pressure and meet deadlinesHighly motivated self-starter and team workerAbility to work in a team-based environment and manage a wide range of specific tasksGood organizational, coordination, and communication skillsFlexibleHighly motivatedGreat TeammateWhat are some of the benefits of working at Baxter?
We offer a competitive total compensation package, with professional development opportunities, where high importance is placed on work-life balance!
Equal Opportunity Employer Statement: Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Reasonable Accommodation Statement: Baxter Healthcare Corporation is committed to providing reasonable accommodations to applicants with disabilities. If you require a reasonable accommodation during the application process, please let us know.
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!
We encourage you to apply today if you resonate with the above responsibilities and requirements.
#LI-LR1Reasonable 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. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
145819 88/89 Furze Road Sandyford Ind Est|Dublin|Co. Dublin|Ireland
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