CrawlJobs Logo
Baxter Logo Baxter · Quality Control

Qualified Person

Ireland, Dublin · Job Posted March 13, 2026
Apply Position
Job Link Share

Job Description

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.

Job Responsibility

  • Release of Nutrition, Chemo and Antibiotic products
  • Oversight and quality assurance expertise and guidance of the compounding process
  • Ensure all products released comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards
  • Responding to pharmaceutical queries concerning compounded medicinal products
  • Support facility projects including process development and quality improvement initiatives
  • 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
  • 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
  • Performance and supervision of recall assessment
  • Training of Quality and Manufacturing personnel
  • Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP)
  • Maintenance of professional status and standards

Requirements

  • 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
  • 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

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
Baxter - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Qualified Person

8 matching positions

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
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
Job Responsibility
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
What we offer
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
  • Fulltime
Read More
Arrow Right

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
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
Job Responsibility
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
What we offer
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
  • Fulltime
Read More
Arrow Right

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
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
Job Responsibility
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
What we offer
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
  • Fulltime
Read More
Arrow Right

Qualified Person

Joining Moderna offers the unique opportunity to be part of a pioneering team th...
Location
Location
United Kingdom , Oxford
Salary
Salary:
Not provided
modernatx.com Logo
Moderna
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A Life Science degree and/or relevant postgraduate qualification, with a minimum of 10 years’ experience in quality roles within the biotechnology and/or pharmaceutical industry
  • Eligibility to act as a Qualified Person (QP), with demonstrable knowledge of biologics and sterile manufacturing sufficient to be named on the site’s licences issued by the MHRA
  • Commitment to maintaining QP status through ongoing Continuing Professional Development
  • Experience working in GMP-regulated pharmaceutical / biological manufacturing environments
  • Expert knowledge of Pharmaceutical Quality Management Systems, including their application across the product lifecycle
  • Extensive understanding of GxP requirements for both early-phase clinical trial materials and commercial products, including interpretation and application of EU GMP and associated MHRA guidance
  • Demonstrated, in-depth understanding of broader GMP principles, industry standards, and current trends shaping the regulatory landscape
  • Experience as a qualified pharmaceutical auditor (internal and/or external)
  • Proven experience hosting and participating in regulatory inspections (e.g., MHRA, FDA, EMA)
  • Demonstrated ability to influence cross-functional teams, provide leadership and drive organisational change.
Job Responsibility
Job Responsibility
  • Acting as the named Qualified Person (QP) on Moderna’s site licence(s)
  • Certifying and authorising batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance
  • Ensuring sterile drug product batches meet cGMP, approved specifications, and the conditions of the Marketing or Clinical Trial Authorisation
  • Maintaining oversight of the PQS as it pertains to QP responsibilities, ensuring it is fit for purpose
  • Escalating GMP or product quality concerns related to safety and efficacy to senior leadership
  • Participating as a member of the site and country Quality teams, promoting strong quality culture and QRM principles
  • Attending and reporting at the Quality Management Review Forum
  • Overseeing delegated activities and ensuring proper training of personnel or third parties
  • Leading or participating in self-inspections, external audits, and Quality Risk Assessments
  • Serving as the QP point of contact for Technical/Quality Agreement reviews and approvals
What we offer
What we offer
  • Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being with access to fitness, mindfulness, and mental health support
  • Family building benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investments to help you plan for the future
  • Fulltime
Read More
Arrow Right

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 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
  • Good problem solving and investigation skills
Job Responsibility
Job Responsibility
  • Release of Nutrition, Chemo and Antibiotic products
  • Oversight and quality assurance expertise and guidance of the compounding process
  • Ensure all products released comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards
  • 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
  • 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
  • Supporting the preparation of Deviation and QA trend reports
  • Supporting the preparation of Key Performance Indicators (KPIs)
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
Read More
Arrow Right

Qualified Person

We have an exciting opportunity for a Qualified Person to join us at Alliance Me...
Location
Location
United Kingdom , Keele
Salary
Salary:
Not provided
alliancemedical.co.uk Logo
Alliance Medical Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Third level qualification in a scientific discipline – pharmacy, medicine, chemistry, pharmaceutical chemistry and biology
  • Diploma in Pharmaceutical Manufacturing Technology
  • Minimum 3 years practical experience in quantitative and qualitative analyses of active substances and necessary testing and checking to ensure quality of medicinal products
  • Experience as a Qualified Person
  • Management experience and responsibility for a Quality Management System
  • Experience as a releasing QP within Radiopharmaceuticals/steriles on a UK MHRA licence
Job Responsibility
Job Responsibility
  • Batch release of Radiopharmaceuticals for use in diagnostic PET scanning
  • Contributing to the management of QMS
  • Overseeing the release of medicinal products for distribution, ensuring compliance with all relevant regulations and guidelines
  • Reviewing and approving batch records, analytical data, and other documentation related to the manufacturing and testing of medicinal products
  • Investigating and resolving quality issues and deviations related to manufacturing processes and materials
  • Participating in internal and external audits of the manufacturing facilities and quality systems
  • Providing expertise and guidance on regulatory requirements and quality standards to internal teams
  • Fulltime
Read More
Arrow Right

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Ireland , Dublin
Salary
Salary:
Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 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
  • Good problem solving and investigation skills
Job Responsibility
Job Responsibility
  • Release of Nutrition, Chemo and Antibiotic products
  • Oversight and quality assurance expertise and guidance of the compounding process
  • Ensure all products released comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards
  • Responding to pharmaceutical queries concerning compounded medicinal products
  • Support facility projects including process development and quality improvement initiatives
  • 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
  • Supporting the preparation of Deviation and QA trend reports
  • Supporting the preparation of Key Performance Indicators (KPIs)
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Fulltime
Read More
Arrow Right

Qualified Person

We have an exciting opportunity for a Qualified Person to join us at Alliance Me...
Location
Location
United Kingdom , Dinnington
Salary
Salary:
95000.00 - 100000.00 GBP / Year
alliancemedical.co.uk Logo
Alliance Medical Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Third level qualification in a scientific discipline (pharmacy, medicine, chemistry, pharmaceutical chemistry, biology)
  • Fulfilled education requirements for the role of Qualified Person (e.g., diploma in Pharmaceutical Manufacturing Technology)
  • Minimum 3 years practical experience in quantitative and qualitative analyses of active substances and necessary testing to ensure quality of medicinal products
  • Experience as a releasing QP within Radiopharmaceuticals/steriles on a UK MHRA licence (preferable)
  • Management experience and responsibility for a Quality Management System
  • Strong background in pharmaceutical manufacturing, quality assurance, and regulatory compliance
  • Excellent attention to detail and problem-solving skills
Job Responsibility
Job Responsibility
  • Batch release of Radiopharmaceuticals for use in diagnostic PET scanning
  • Contributing to the management of QMS
  • Overseeing the release of medicinal products for distribution, ensuring compliance with all relevant regulations and guidelines
  • Reviewing and approving batch records, analytical data, and other documentation related to the manufacturing and testing of medicinal products
  • Investigating and resolving quality issues and deviations related to manufacturing processes and materials
  • Participating in internal and external audits of the manufacturing facilities and quality systems
  • Providing expertise and guidance on regulatory requirements and quality standards to internal teams
  • Fulltime
Read More
Arrow Right