Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!
At Ipsen we are committed to improving the lives of patients with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder reflecting our commitment to excellence innovation and continuous improvement.
With a recent 24 million investment in the site and a further 86.4 million expansion underway there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth innovation and excellence then Ipsen could be where you thrive!
Role summary
As a QA Specialist NDP you will play a key role in supporting a brand-new pharmaceutical manufacturing facility ensuring robust quality oversight operational readiness and compliance with GMP requirements. You will partner closely with cross-functional teams to enable successful facility qualification commercialisation and ongoing manufacturing excellence.
In this role you will:
Provide Quality Assurance oversight for the development and implementation of processes and procedures for the new Building 7 facility ensuring alignment with GMP and Ipsen standards.
Review and maintain key operational documentation (SOPs batch records logbooks) and support deviation investigations CAPAs change controls and OOS events.
Perform batch record review and provide real-time QA oversight during manufacturing activities to ensure compliant and timely batch release.
Act as a technical QA expert supporting troubleshooting resolving complex issues and contributing to site projects and regulatory inspections readiness.
Deliver training and guidance on quality standards procedures and documentation to site teams enabling a smooth transition to routine operations.
Drive continuous improvement by analysing quality metrics identifying opportunities and promoting a proactive quality culture across the site.
Requirements:
Significant QA experience within the pharmaceutical or biopharmaceutical industry
Strong knowledge of GMP validation principles and regulatory expectations
Experience in batch record review and supporting batch release activities
Excellent communication problem-solving and organisational skills
Ability to work both independently and collaboratively in a fast-paced evolving environment
Degree diploma or equivalent in a scientific discipline
Preferred:
Extensive QA experience particularly within sterile or aseptic manufacturing environments
Knowledge of EU GMP Annex 1 and contamination control strategies
Experience supporting new facility start-up expansion or technology transfer projects
Familiarity with cleanroom environments (Grade A/B) aseptic techniques and gowning practices
Experience with quality systems such as SAP Blue Mountain or electronic QMS platforms
Understanding and application of ICH Q9 Quality Risk Management principles
#LI-Onsite
We are committed to creating a workplace where everyone feels heard valued and supported; where we embrace The Real Us. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.
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IC
Title:QA Specialist NDPCompany:Ipsen Biopharm LtdAbout Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in ...
Title:
QA Specialist NDP
Company:
Ipsen Biopharm Ltd
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!
At Ipsen we are committed to improving the lives of patients with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder reflecting our commitment to excellence innovation and continuous improvement.
With a recent 24 million investment in the site and a further 86.4 million expansion underway there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth innovation and excellence then Ipsen could be where you thrive!
Role summary
As a QA Specialist NDP you will play a key role in supporting a brand-new pharmaceutical manufacturing facility ensuring robust quality oversight operational readiness and compliance with GMP requirements. You will partner closely with cross-functional teams to enable successful facility qualification commercialisation and ongoing manufacturing excellence.
In this role you will:
Provide Quality Assurance oversight for the development and implementation of processes and procedures for the new Building 7 facility ensuring alignment with GMP and Ipsen standards.
Review and maintain key operational documentation (SOPs batch records logbooks) and support deviation investigations CAPAs change controls and OOS events.
Perform batch record review and provide real-time QA oversight during manufacturing activities to ensure compliant and timely batch release.
Act as a technical QA expert supporting troubleshooting resolving complex issues and contributing to site projects and regulatory inspections readiness.
Deliver training and guidance on quality standards procedures and documentation to site teams enabling a smooth transition to routine operations.
Drive continuous improvement by analysing quality metrics identifying opportunities and promoting a proactive quality culture across the site.
Requirements:
Significant QA experience within the pharmaceutical or biopharmaceutical industry
Strong knowledge of GMP validation principles and regulatory expectations
Experience in batch record review and supporting batch release activities
Excellent communication problem-solving and organisational skills
Ability to work both independently and collaboratively in a fast-paced evolving environment
Degree diploma or equivalent in a scientific discipline
Preferred:
Extensive QA experience particularly within sterile or aseptic manufacturing environments
Knowledge of EU GMP Annex 1 and contamination control strategies
Experience supporting new facility start-up expansion or technology transfer projects
Familiarity with cleanroom environments (Grade A/B) aseptic techniques and gowning practices
Experience with quality systems such as SAP Blue Mountain or electronic QMS platforms
Understanding and application of ICH Q9 Quality Risk Management principles
#LI-Onsite
We are committed to creating a workplace where everyone feels heard valued and supported; where we embrace The Real Us. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.
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