Qualified Person Job at Baxter (Dublin)

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

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
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
Ensuring 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
Investigate customer complaints/quality defects
Coordination and performance of corrective and preventive action investigations (CAPAs)
Ensure 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
QA approval of environmental monitoring results and trends
Support introduction of new products
Review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations, and project validation/plans
Support timely release of equipment, utilities, facilities, and computer systems following execution of test protocols
Provide support in other Quality roles as needed

Requirements

Pharmacy Degree (or equivalent experience) in a science-related field
QP Qualification
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

What we offer

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance
Life Assurance
Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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