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Purchasing & Planning Manager
Wexford
Wexford
Quality Engineer
Athlone
Athlone
R&D Technician
Galway
Galway
Senior R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Electronic Engineering
Dublin
Dublin
Senior R&D Engineer
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Galway
Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Project Manager
Kildare
Kildare
Quality Engineer
Galway
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Product Development Engineer
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Dublin
R&D Director
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Galway
Process Engineer
Carlow
Carlow
Quality Engineer
Galway
Galway
Mechanical Technician
Carlow
Carlow
Project Engineer
Clare
Clare
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
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Dublin
Project Manager - R&D
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Galway
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Kilkenny
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Dublin
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Athlone
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Galway
Quality Specialist
Clare
Clare
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Galway
R&D Engineer
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Dublin
Quality Manager
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Dublin
Director of Quality Engineering
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Galway
Quality Systems Manager
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Dublin
Senior R&D Engineer
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Galway
Design Quality Engineer
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Galway
Quality Specialist & Deputy RP
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Limerick
Injection Molding Engineer
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North Leinster
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Athlone
Electronic Engineer
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Dublin
Quality Operations Manager
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Dublin
Strategic Automation Lead
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Waterford
Quality Specialist
Clare
Clare
Embedded Software Engineer
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Dublin
Manufacturing Engineer
Wexford
Wexford
Manufacturing Technician
Clare
Clare
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior QA Specialist (hybrid)
Tipperary
Tipperary
Production Manager
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Dublin
Senior Quality Engineer
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Leitrim
Senior R&D Engineer
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Dublin
CTO
Dublin
Dublin
Operations Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Program Manager
Dublin
Dublin
Quality Manager
Galway
Galway
Principal R&D Engineer
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Dublin
Senior Operations Engineer
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Galway
Senior Microbiologist
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Dublin
Senior Quality Engineer
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Leitrim
Injection Molding Engineer
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North Leinster
Process Engineer
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Galway
Electronic Engineer
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Dublin
Purchasing & Planning Manager
Wexford
Wexford
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Product Development Engineer II
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Galway
Senior R&D Engineer
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Sourcing Specialist
Tipperary
Tipperary
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Dublin
Quality Manager
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Galway
Principal Device Engineer
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Dublin
R&D Engineer
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Galway
Process Chemist
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Limerick
Quality Specialist (Shift)
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Dublin
R&D Technician II
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Galway
Facilities Engineer
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Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Project Manager - R&D
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Galway
Senior Design Engineer
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Dublin
Senior Process Engineer
Dublin
Dublin
Senior Design Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Design Assurance Engineer
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Galway
Quality Specialist
Tipperary
Tipperary
Product Development Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Senior Electronics Engineer
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Principal R&D Engineer
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Galway
Senior R&D Engineer
Galway
Galway
Senior Maintenance Technician
Roscommon
Roscommon
Manufacturing Technician
Clare
Clare
DeltaV Technical Coordinator - Hybrid
Tipperary
Tipperary
Project Manager - R&D
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Galway
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Meath
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Carlow
Carlow
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Dublin
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Galway
Senior R&D Manager
Athlone
Athlone
Senior Quality Engineer
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Galway
Product Development Engineer II
Athlone
Athlone
QA Manager
Canada
Canada
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Wexford
Quality Engineer
Galway
Galway
Product Development Engineer
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Galway
Project Manager
Louth
Louth
R&D Engineer
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Galway
Product Development Engineer
Galway
Galway
Maintenance & Reliability Technician
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Limerick
Senior Quality Engineer
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Dublin
Staff Systems Engineer
Limerick
Limerick
R&D Engineer
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Galway
Principal Software Engineer
Athlone
Athlone
R&D Technician II
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Galway
Principal Engineer
Dublin
Dublin
Product Development Engineer II
Athlone
Athlone
Project Engineer
Limerick
Limerick
Injection Molding Engineer
North Leinster
North Leinster
Senior Electronic Engineer
Dublin
Dublin
Principal Process Equipment Engineer
Dublin South
Dublin South
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Team Leader - Lab Services
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Dublin
Senior R&D Engineer
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Galway
Manufacturing Engineer
Galway
Galway
R&D Project Manager
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Injection Moulding Engineer
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Leitrim
Manufacturing Technician
Clare
Clare
Injection Moulding Engineer
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Athlone
Project Manager
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R&D Director
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Galway
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Meath
R&D Manager
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Athlone
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Galway
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Meath
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Cavan
Principal R&D Engineer
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Principal Engineer
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Project Engineer
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Health & Safety Specialist
Dublin
Dublin
Quality Engineer
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Principal R&D Engineer
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Dublin
Senior R&D Engineer
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Galway
R&D Engineer
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Galway
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Galway
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Dublin South
Dublin South
Regulatory Associate
Cork
Cork
Principal Engineer
Dublin
Dublin
Biomedical Engineer
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Dublin
Quality Manager
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Dublin
R&D Manager
Galway
Galway
R&D Manager
Galway
Galway
Calibration Technician
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
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Galway
Quality Engineer
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Galway
Senior R&D Engineer
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Galway
Senior Quality Engineer
Dublin
Dublin
Quality Engineer
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Athlone
Site Microbiologist
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Clare
Clare
Senior R&D Engineer
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Galway
R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Principal R&D Engineer
Galway
Galway
Senior Design Engineer
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Dublin
Senior Quality Engineer
Leitrim
Leitrim
Project Manager (hybrid)
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Dublin
CAPA Specialist
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Cavan
Change Control SME
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Cork
Senior Quality Engineer
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Leitrim
Project Engineer
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Roscommon
Maintenance CMMS Engineer
Tipperary
Tipperary
Documentation Specialist
Louth
Louth
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
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Senior Regulatory Affairs
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Galway
Product Development Manager
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Galway
R&D Director
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Galway
Product Development Engineer
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Dublin
Electronic Engineer
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Dublin
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Cavan
Manufacturing Technician
Clare
Clare
CTO
Galway
Galway
Engineering Business Manager
Dublin
Dublin
Process Development Engineer
Galway
Galway
R&D Manager
Connaught
Connaught
Manufacturing Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Associate Director - Manufacturing &
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Limerick
Senior Equipment Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Documentation Specialist
Louth
Louth
Principal R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Reg Affairs Specialist
Connaught
Connaught
R&D Engineer
Galway
Galway
Maintenance & Reliability Technician
Limerick
Limerick
Purchasing & Planning Manager
Wexford
Wexford
Manufacturing Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Quality Manager - Medical Devices
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Limerick City
R&D Lifecycle Manager
Connaught
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Senior Mechanical Engineer
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Senior Electronics Engineer
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Quality Engineer
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Galway
Quality Technician
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Dublin
R&D Manager
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Continuous Improvement Coach
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Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior R&D Manager
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Athlone
R&D Engineer
Clare
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Quality Assurance Engineer
Longford
Longford
Senior Engineering Manager
Limerick
Limerick
R&D Engineer
Dublin
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Senior R&D Engineer
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Galway
Process Engineer
Dublin
Dublin
Senior Operations Engineer
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Galway
Quality Engineer
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Galway
R&D Manager
Connaught
Connaught
Manufacturing Technician
Clare
Clare
Documentation Specialist
Louth
Louth
Utilities Engineer
Dublin
Dublin
Documentation Specialist
Louth
Louth
Senior R&D Engineer
Clare
Clare
Product Development Manager
Galway
Galway
R&D Manager
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Galway
QA Engineer
Leitrim
Leitrim
R&D Manager
Connaught
Connaught
Team Leader - Lab Services
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Senior Design Assurance Engineer
Athlone
Athlone
Principal Quality Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
R&D Manager
Galway
Galway
Principal Instrumentation & Calibrat
Limerick
Limerick
Procurement Associate
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Staff R&D Engineer
Limerick
Limerick
Product Development Engineer
Dublin
Dublin
Project Manager
Galway
Galway
Warehouse Operator
Meath
Meath
Project Manager - R&D
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Galway
Product Development Engineer
Dublin
Dublin
R&D Manager
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
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Galway
Production Operator
Carlow
Carlow
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Meath
Meath
Senior Research & Development Engine
Limerick
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R&D Program Manager
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R&D Senior Program Manager
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Galway
Electronic Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
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Dublin
Dublin
Principal R&D Engineer
Galway
Galway
R&D Engineer
Galway
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Westmeath
Westmeath
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Please view a sample career profile in the box below
or click here to browse all open vacancies
Qualified Person Career Profile
Qualified Person (QP)
The QP is the person responsible for the final release of a batch of pharmaceutical product, finished products that are ready for consumption only. To do this, they must review all of the batch files, which encompass information from many of the other departments. A QP is named on a manufacturing licence and must be qualified according to Directive 2003/94/EC. This is granted by taking a specific 2 year course, or by having a Pharmacy degree plus the required experience. Salaries in this area range from €60,000 to €90,000 for an experienced QP. Many QPs also offer their services on contract, services numerous facilities simultaneously. A desireable and lucrative job for many working in the Pharmaceutical industry.Minimum of five years experience in a Quality role.
Key Responsibilities of the QP
- Before certifying a batch prior to release the Qualified Person doing so should always ensure that the following requirements have been met:
- Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released for sale or supply in the EC/EEA or for export.
- The principles and guidelines of GMP as stated in Directive 2003/94/EC for medicinal products and IMP for human use, as interpreted in the EC Guide to GMP have been followed. Ensure all requirements under references have been met prior to release of a batch.
- The principal manufacturing and testing processes have been validated.
- All the necessary Quality Control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records.
- All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
- All necessary manufacturing, packaging and quality control documentation has been completed and endorsed by suitably authorised staff.
- To ensure that the legal requirements regarding imported products have been fully met.
- The general conditions as laid down on the Manufacturer's License orManufacturing Authorisation (IMB) are followed.
- The QP should maintain their knowledge and experience up-to-date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.
- The QP must carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study.
- The QP must maintain a register of all released batches.
-
The QP must promote GMP through training and guidance internally.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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