Qualified Person Job at Alliance Medical Ltd (Keele)

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

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

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

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

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

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

Qualified Person

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United Kingdom , Oxford

Salary:

Not provided

Moderna

Expiration Date

Until further notice

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

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

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

Qualified Person

The Qualified Person (QP) is primarily responsible for release of Nutrition, Che...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Qualified Person

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qualified Person

We have an exciting opportunity for a Qualified Person to join us at Alliance Me...

Location

United Kingdom , Dinnington

Salary:

95000.00 - 100000.00 GBP / Year

Alliance Medical Ltd

Expiration Date

Until further notice

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

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

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