Qualified Person
2 weeks ago
Qualified Person Let’s do this. Let’s change the world. In this QP role you will own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.* Ensure that each batch of medicinal product is manufactured and checked in compliance with EU Good Manufacturing Practice (GMP), the product’s marketing authorization (MA), and relevant legal requirements, prior to its release.* Perform review and approval of validation documentation.Maintain a close contact and familiarity with Amgen Quality systems and programs utilized at other Amgen sites.Perform activities as required per Amgen procedures as QA staff, and in particular where the role of QP is specified in the procedures. Displays critical thinking expertise, with the ability to define and implement a strategic approach to audits and inspections, based on compliance and business knowledge.Ability to effectively plan, organize, and execute work that ensures deliverables are consistently met. **Basic Qualifications:** OR University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation. Knowledge of applicable regulatory requirements As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Qualified Person
2 weeks ago
Dublin, Ireland Amgen Inc. (Ir) Full timeQualified Person Let's do this.Let's change the world.In this QP role you will own, review and approve SOP's and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.* Ensure that each batch of medicinal product is manufactured and checked in compliance with EU Good Manufacturing Practice (GMP), the...
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Qp - Qualified Person
3 weeks ago
Dublin, Ireland Cai Full timeAbout CAI:CAI is a 100% employee-owned company established in ****, that has grown year over year to nearly 850 people worldwide.We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.Are you Ready?Our approach is simple;...
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QP - Qualified Person
3 days ago
Dublin, Ireland CAI Full timeAbout CAI: CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are you Ready? Our approach is...
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QP - Qualified Person
4 weeks ago
Dublin Pike, Ireland CAI Full timeGet AI-powered advice on this job and more exclusive features. About CAI CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other...
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Qualified Person
2 weeks ago
Dublin, Ireland AstraZeneca GmbH Full timeOverview Are you ready to make a significant impact in the world of biopharmaceuticals? As a Qualified Person (QP) at Alexion, you will play a crucial role in ensuring that both licensed Finished Products and Investigational Medicinal Products (IMP) are certified and released in compliance with EU directives and Annex requirements. Your leadership will...
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Qualified Person
3 weeks ago
Dublin, Ireland Astrazeneca Gmbh Full timeOverviewAre you ready to make a significant impact in the world of biopharmaceuticals?As a Qualified Person (QP) at Alexion, you will play a crucial role in ensuring that both licensed Finished Products and Investigational Medicinal Products (IMP) are certified and released in compliance with EU directives and Annex requirements.Your leadership will guide...
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Qualified Person
2 weeks ago
Dublin, Ireland Amgen Sa Full timeOverviewJoin Amgen's Mission of Serving Patients.At Amgen, if you feel like you're part of something bigger, it's because you are.Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since ****, we've helped pioneer biotechnology in our fight against the world's toughest diseases.With our focus on four therapeutic...
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Qualified Person QP
1 week ago
Dublin, Ireland Cpl Full timeQualified Person - QPOn behalf of our client, a leading medical device & healthcare company, we are currently recruiting for a Qualified Person. Based in the Dublin location, this is a part time flexible opportunity.Ensure that the quality system is implemented and maintained in such a way to ensure that all services provided to B Braun Customer’s meet...
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Qualified Person
3 weeks ago
Dublin, Ireland Clinigen Full timeClinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle.We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa.Clinigen is growing rapidly and is positioned well...
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Radiopharmacy Head Of Quality Assurance
4 weeks ago
Dublin, Ireland Alliance Medical Ireland Full timeOverviewAlliance Medical Ireland are hiring a Radiopharmacy Head of Quality Assurance (Qualified Person) to lead the QA team and safeguard product quality, patient safety and regulatory compliance.This is a full-time (37.5 hours per week), permanent role.Closing date: Friday 19 September 2025.ResponsibilitiesCoordinate and lead all QA activities.Regularly...
