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Process Engineer
Limerick
Limerick
EHS Specialist
Cork
Cork
Senior Quality Engineer
Limerick
Limerick
Senior Scientist
Dublin
Dublin
Senior CSV Specialist- Hybrid/Remote
Republic of Ireland
Republic of Ireland
Equipment Project Engineer
Limerick
Limerick
Analytical Chemist
Cork
Cork
Director of Quality Engineering
Limerick
Limerick
Lean Six Sigma Coach
Cork
Cork
Utilities Engineer
Dublin
Dublin
GCP Inspector
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Regulatory Affairs Director
Dublin
Dublin
R&D Manager
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Senior Project Manager
Dublin
Dublin
Senior Associate QC
Dublin
Dublin
R&D Senior Program Manager
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Lean Expert
Cork
Cork
Quality Assurance Specialist
Tipperary
Tipperary
Maintenance Engineer
Cork
Cork
Associate QC (Senior)
Dublin
Dublin
Process Engineer
Limerick
Limerick
Process Team Lead
Donegal
Donegal
Senior Engineering Manager
Limerick
Limerick
Senior QC Microbiology
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior Technical Writer
Dublin
Dublin
Validation Engineer
Wicklow
Wicklow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Project Engineer
Limerick
Limerick
QC Team Leader
Cork
Cork
Head of R&D
Galway
Galway
Project Readiness Lead
Limerick
Limerick
Senior Supply Chain Planner
Dublin
Dublin
Process Engineer
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Mechanical Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Maintenance Engineer
Cork
Cork
Senior Project Engineer
Limerick
Limerick
Manufacturing Engineer
Galway
Galway
Project Manager
Limerick
Limerick
Validation Engineer
Carlow
Carlow
Manufacturing Engineer
Limerick
Limerick
CQV/Validation Engineer
Dublin
Dublin
Laboratory Technician
Dublin
Dublin
Project Engineer
Republic of Ireland
Republic of Ireland
CSV Engineer
Limerick
Limerick
Process Engineer
Galway
Galway
R&D Manager
Galway
Galway
Microbiology Manager
Dublin
Dublin
Project Engineer
Limerick
Limerick
Product Planner
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior R&D Engineer
Limerick City
Limerick City
Quality Engineer
Cork
Cork
R&D Engineer
Limerick City
Limerick City
QA Specialist
Meath
Meath
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Operations Manager
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Process Engineer
Galway
Galway
Manufacturing Specialist
Dublin South
Dublin South
Project Engineer
Limerick
Limerick
Project Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Warehouse Manager
Louth
Louth
Biostatistician
Cork
Cork
Controls Engineer
Dublin South
Dublin South
Operations Engineer
Dublin
Dublin
Equipment Project Engineer
Limerick
Limerick
Project Document Controller
Dublin
Dublin
Senior Manager
Dublin
Dublin
Program Manager
Galway
Galway
Engineering Technician
Dublin South
Dublin South
Equipment Project Engineer
Limerick
Limerick
Manufacturing Engineer
Wexford
Wexford
CAD Technician
Republic of Ireland
Republic of Ireland
Strategic Automation Lead
Waterford
Waterford
CMC Director
Dublin
Dublin
Senior Project Engineer
Dublin
Dublin
Senior Project Manager
Limerick
Limerick
QC Leader
Cork
Cork
Director, Clinical Development (Oncology
South East
South East
Senior CSV Specialist- Hybrid
Republic of Ireland
Republic of Ireland
Maintenance Reliability Engineer
Tipperary
Tipperary
Bioprocess Associate
Dublin
Dublin
Quality Systems Specialist
Galway
Galway
Quality Manager
Kerry
Kerry
Quality Engineer
Limerick
Limerick
Project Manager
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
Senior Technical Writer
Dublin
Dublin
EHS Specialist
Cork
Cork
Materials Engineer
Cork
Cork
Senior Validation Engineer
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
Quality Engineer II
Galway
Galway
Quality Engineer
Wexford
Wexford
Maintenance CMMS Engineer
Tipperary
Tipperary
VP Clinical Development
Republic of Ireland
Republic of Ireland
Senior R&D Clinical Engineer
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Process Engineer
Limerick
Limerick
Production Team Lead
Dublin South
Dublin South
Process Team Lead
Donegal
Donegal
Service Sales Representative
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
Quality Engineer - Validation
Limerick
Limerick
Electronic Design Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Process Team Lead
Donegal
Donegal
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior R&D Engineer
Dublin
Dublin
Senior Technical Support ScientisT
Longford
Longford
QC Bioanalytical Analyst
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Maintenance Engineer
Dublin
Dublin
Quality Engineer
Limerick
Limerick
Clinical Program Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Quality Team Leader
Louth
Louth
Senior Validation Engineer
Limerick
Limerick
Principal Research Engineer
Galway
Galway
Medical Affairs Indication Lead
Cork City
Cork City
Regulatory Affairs Specialist
Republic of Ireland
Republic of Ireland
Senior Mechanical Engineer
Dublin
Dublin
EHS Specialist
Cork
Cork
Medical Device Director
Republic of Ireland
Republic of Ireland
Quality Engineer
Dublin
Dublin
Quality Systems Specialist
Limerick
Limerick
Principal Research Engineer
Galway City
Galway City
Principal CAD Experience
Dublin
Dublin
Quality Engineer
Dublin
Dublin
Specialist Scheduler
Dublin
Dublin
Senior Electronic Engineer
Limerick
Limerick
Project Engineer
Cork
Cork
Senior R&D Engineer
Galway
Galway
Senior R&D Project Manager
Galway
Galway
MDR/Vigilance Specialist
Galway
Galway
R&D Engineer
Galway
Galway
QA Specialist
Cork
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Project Engineer
Limerick
Limerick
C&Q Engineer
Dublin
Dublin
Project Engineer
Limerick
Limerick
R&D Director
Galway
Galway
QC Bioassay Analyst
Cork
Cork
Senior Quality Engineer
Galway
Galway
Associate Scientist
Cork
Cork
Assoc Quality Engineer
Galway
Galway
Validation Engineer
Limerick
Limerick
Quality Specialist
Tipperary
Tipperary
Search Results for Qualified Person
Job Title. | Location | Salary | Actions |
Qualified Person - PharmaceuticalQA Specialist/QP Description My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of the company, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide. As QA Specialist/QP, you will manage and drive the site QA systems in close cooperation with other specia...Location: Cork, Cork City, |
Cork | Not Disclosed |
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.
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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
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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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