Qualified Person QP
1 week ago
Qualified 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 both internal and external requirements, including EU Regulations and HPRA Guidelines for Good Manufacturing Practice (GMP), Corporate and Customer requirements.Core Responsibilities/Authority:·Ensure that the quality system is implemented and maintained.·Ensure that the conditions of the Manufacturers/Importers Authorisation (MIA) are being complied with and that the GMP guidelines are being followed. ·Ensure that the quality, safety and traceability of MIA medicinal products are maintained within the supply chain.·Ensure appropriate competence and experience as well as knowledge of and training in GMP. ·Ensure that items affecting the Safety, Identity, Strength, Purity, or Quality (SISPQ) of the Product are actioned appropriately.·Fulfil responsibilities personally. ·Carry out their duties in such a way as to ensure that the MIA holder can demonstrate GMP compliance and that public service obligations are met. To succeed in this role, we imagine that you have the following qualifications: Minimum of BSc Degree or equivalent third level education Qualified Person Status in accordance with EC DirectivesMinimum 2 years, experience in quality or production function within the pharmaceutical industryFor a full Job Spec and to apply for this role please call Linda on 01 or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 #LI-TD1
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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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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
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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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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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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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),...
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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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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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Associate Director QA
4 weeks ago
Dublin, Ireland Amgen Full timeOverview The Primary QP role involves acting as the main Qualified Person (QP) on the Amgen Technology Ireland (ATI) manufacturing license. This position provides scientific, quality, compliance, and patient-centered support to the ATI manufacturing site. It includes supporting daily Quality activities related to technical issues with Amgen products and...
