Qp & Quality Manager Compounding Job at Baxter (Dublin)

Qp & Quality Manager Compounding

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

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
Act as a Qualified Person (QP) responsible for implementing the quality management system
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Pension
Competitive package
Health Insurance
Life Assurance and much more
Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qp & Quality Manager Compounding

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

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
Act as a Qualified Person (QP) responsible for implementing the quality management system
Lead all aspects of the compounded products release process
Ensure strict adherence to regulatory and customer requirements
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Pension
Competitive package
Health Insurance
Life Assurance
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qp & Quality Manager Compounding

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

Location

Ireland , Sandyford Dublin 18

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
Act as a Qualified Person (QP) responsible for implementing the quality management system
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Pension
Competitive package
Health Insurance
Life Assurance and much more

Fulltime

Qp & Quality Manager Compounding

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

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4 and Commission Directive 2003/94/EEC
Act as a Qualified Person (QP) responsible for implementing the quality management system and lead all aspects of the compounded products release process
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and product quality issues
Develop and maintain an internal review process to ensure continuous compliance
Lead and manage the audit process for the facility
Measure and analyze site quality metrics and implement data-driven actions for continuous improvement
Develop and implement risk management strategies to minimize product and process risks
Coordinate the management, execution, and approval of quality documents and records including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Pension
Competitive package
Health Insurance
Life Assurance and much more
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Qp & Quality Manager Compounding Sandyford Dublin 18

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

6-10 years experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
Act as a Qualified Person (QP) responsible for implementing the quality management system
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time
Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly
Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Pension
Competitive package
Health Insurance
Life Assurance and much more
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Releaser, QA

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

Degree or equivalent experience in science-related field essential
Pharmacy degree preferable
Previous experience in a pharmaceutical company or equivalent-type role
Ideally a minimum of 2 years’ experience in a GMP regulated aseptic environment
Experience/qualifications in microbiology/environmental monitoring a distinct advantage

Job Responsibility

Ensure compliance with cGMP, corporate standards/Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements, and industry standards
Batch Disposition
Inspection and batch release of compounded products under the supervision of a Qualified Person (QP)
Responsible for reviewing production and batch records for completeness and releasing product
Liaising with the QPs (qualified persons) responsible for product release
Performing quality review of orders prior to manufacture
Liaising with Dispatch and customer service to manage quality issues and timely customer service
Quality approval of environmental monitoring results and preparation of trends
Stability
Facilitating, reviewing, updating, and maintaining stability data on the system when required and in accordance with the annual stability review schedule

What we offer

Pension
Health Insurance
Life Assurance
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 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

Releaser, QA

A Quality Batch Releaser is responsible for carrying tasks pertaining to complia...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree or equivalent experience in science-related field essential
Pharmacy degree preferable
Previous experience in a pharmaceutical company or equivalent-type role. Ideally a minimum of 2 years’ experience in a GMP regulated aseptic environment
Experience/qualifications in microbiology/environmental monitoring a distinct advantage
Highly motivated
Meticulous in attention to professional standards
Respond well to time constraints with an ability to work in a dynamic, fast-paced and goal driven environment
Ability to work in a team-based environment with good communication, influencing and interpersonal skills
Ability to manage a wide range of specific tasks
Excellent organisational and coordination skills

Job Responsibility

Ensure compliance with cGMP, corporate standards/Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements, and industry standards
Batch Disposition
Inspection and batch release of compounded products under the supervision of a Qualified Person (QP)
Responsible for reviewing production and batch records for completeness and releasing product
Liaising with the QPs (qualified persons) responsible for product release
Performing quality review of orders prior to manufacture
Liaising with Dispatch and customer service to manage quality issues and timely customer service
Quality approval of environmental monitoring results and preparation of trends
Stability
Facilitating, reviewing, updating, and maintaining stability data on the system when required and in accordance with the annual stability review schedule

What we offer

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

Fulltime

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Qp & Quality Manager Compounding

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Qp & Quality Manager Compounding

Qp & Quality Manager Compounding

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Qp & Quality Manager Compounding

Qp & Quality Manager Compounding

Qp & Quality Manager Compounding Sandyford Dublin 18

Releaser, QA

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Releaser, QA

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