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Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Specialist
Tipperary
Tipperary
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Belfast City
Belfast City
Quality Assurance Engineer
Longford
Longford
R&D Engineer
Galway
Galway
Manufacturing Technician
Clare
Clare
Senior R&D Engineer
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Galway
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Galway
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Galway
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Galway
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Dublin
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Quality Operations Manager
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Principal Process Equipment Engineer
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Regulatory Associate
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Galway
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Dublin
Product Development Manager
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Principal R&D Engineer
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Galway
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Galway
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Injection Moulding Engineer
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Maintenance & Reliability Technician
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Quality Systems Manager
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Biomedical Engineer
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Lead Maintenance Technician
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Principal R&D Engineer
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Galway
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Galway
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Galway
Product Development Engineer
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Galway
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Galway
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Republic of Ireland
Republic of Ireland
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Galway
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Utilities Engineer
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Connaught
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Galway
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Dublin
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Galway
Senior Design Engineer
Dublin
Dublin
Program Manager
Dublin
Dublin
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Galway
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Dublin
Manufacturing Technician
Clare
Clare
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Maintenance Technician
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Kilkenny
Project Manager - R&D
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Galway
Mechanical Engineer
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Dublin
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Director of Quality Engineering
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Sr Electrical Engineer
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Electronic Engineer
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Senior Recruitment Consultant
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Republic of Ireland
Senior QC Associate
Dublin
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Senior R&D Engineer
Galway
Galway
Electronic Engineering
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Project Manager
Galway
Galway
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
R&D Technician
Galway
Galway
Purchasing & Planning Manager
Wexford
Wexford
Change Control SME
Cork
Cork
Product Development Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Senior QC Associate NPI
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Dublin
Electronic Engineer
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Dublin
Strategic Automation Lead
Waterford
Waterford
Injection Molding Engineer
North Leinster
North Leinster
R&D Engineer
Galway
Galway
Staff Systems Engineer
Limerick
Limerick
Maintenance Manufacturing Technician
Kilkenny
Kilkenny
Senior Operations Engineer
Galway
Galway
Process Development Engineer
Galway
Galway
Senior Equipment Engineer
Dublin
Dublin
Senior R&D Engineer
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Galway
Quality Manager - Medical Devices
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Limerick City
Design Assurance Engineer
Galway
Galway
Injection Molding Engineer
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North Leinster
Senior Mechanical Engineer
Dublin
Dublin
Senior R&D Engineer
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Analytical Scientist
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Quality Manager
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Sr Electrical Engineer
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Process Engineer
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Project Engineer
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Process Engineer
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Roscommon
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Clare
Clare
Project Manager - R&D
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Electronic Engineer
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Responsible Person (RP)
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Republic of Ireland
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Clare
Clare
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Cavan
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Clare
Clare
Senior Electronic Engineer
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Principal Quality Engineer
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Galway
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Dublin
Buyer / Planner
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Sligo
Lead Maintenance Reliability Engineer
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Westmeath
R&D Manager
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
R&D Manager
Connaught
Connaught
Reg Affairs Specialist
Connaught
Connaught
Quality Technician
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Dublin
Manufacturing Engineer
Galway
Galway
Microbiology Manager
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
R&D Director
Galway
Galway
R&D Manager
Galway
Galway
Quality Manager
Dublin
Dublin
R&D Engineer
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Galway
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Galway
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Republic of Ireland
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Galway
Galway
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Athlone
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Facilities Engineer
Carlow
Carlow
Electronic Engineer
Dublin
Dublin
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Carlow
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Dublin South
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Galway
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Galway
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Louth
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Athlone
Athlone
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Quality Engineer
Galway
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R&D Director
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Galway
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Kilkenny
Kilkenny
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Dublin
Dublin
CTO
Dublin
Dublin
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Galway
Galway
Staff R&D Engineer
Limerick
Limerick
Product Development Engineer II
Athlone
Athlone
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Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Documentation Specialist
Louth
Louth
R&D Manager
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Principal Engineer
Dublin
Dublin
Injection Moulding Engineer
Athlone
Athlone
Electronic Engineer
Dublin
Dublin
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Athlone
Athlone
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Documentation Specialist
Louth
Louth
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Galway
Galway
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Galway
Galway
Production Operator
Carlow
Carlow
Injection Molding Engineer
North Leinster
North Leinster
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Dublin
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Project Manager (hybrid)
Dublin
Dublin
EHS Officer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
R&D Engineer
Clare
Clare
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Galway
Galway
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Roscommon
Roscommon
Associate Director - Manufacturing &
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Limerick
Sr Electrical Engineer
Galway
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Limerick
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Galway
Galway
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Galway
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Republic of Ireland
Republic of Ireland
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Clare
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Galway
Galway
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Galway
Galway
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Galway
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Dublin
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Cork
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Other similar job titles you may be intertested in include:
Process Technician
Validation Manager
Technical Services Specialist
Validation Coordinator
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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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
Valid XHTML - CSS



