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
To complete any other activities as directed by Quality management

Requirements

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
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

Nice to have

Experience/qualifications in microbiology/environmental monitoring
Working in a project-based environment
Previous experience as a batch releaser

What we offer

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

Baxter - All Job Offers

Select Country

Qualified Person

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Qualified Person

Qualified Person

Qualified Person

Qualified Person

Personal Injury Solicitor

Holiday Fitness Instructor

Personal Trainer

Mixed Tax Assistant Manager

Defendant Personal Injury Solicitor

Our AI answers in your language