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R&D Manager
Galway
Galway
Manufacturing Technician
Clare
Clare
Director of Quality Engineering
Limerick
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior QC Associate
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Aseptic Process Lead
Carlow
Carlow
Clean Utilities Engineer
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Graduate R&D Engineer
Galway
Galway
QA Associate Specialist
Carlow
Carlow
Quality Technician
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
R&D Senior Program Manager
Galway
Galway
Electronic Design Engineer
Galway
Galway
R&D Manager
Galway
Galway
QC Chemistry Analyst (Shift)
Carlow
Carlow
Digital Lab Records Specialist
Tipperary
Tipperary
Quality Technician
Dublin
Dublin
R&D Manager
Galway
Galway
R&D Manager
Galway
Galway
Senior Process Enginer
Dublin South
Dublin South
Manufacturing Engineer
Galway
Galway
R&D Director
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Manufacturing Engineer
Limerick
Limerick
Project Manager - Suite Lead
Tipperary
Tipperary
QC Analyst
Meath
Meath
QC Chemistry Analyst
Carlow
Carlow
Quality Technician
Dublin
Dublin
Product Development Engineer
Galway
Galway
Clinical Affairs Manager
Galway
Galway
Recruitment Consultant
Wexford
Wexford
Senior Electrical Engineer
Galway
Galway
Design Assurance Engineer
Galway
Galway
Quality Manager
Clare
Clare
Pharmaceutical Operator
Louth
Louth
Quality Systems Specialist
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Project Manager
Louth
Louth
Maintenance Engineer
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Strategic Automation Lead
Waterford
Waterford
Project Engineer
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Project Manager - R&D
Galway
Galway
R&D Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Program Manager
Cork
Cork
Quality Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Quality Engineer
Athlone
Athlone
R&D Program Manager
Dublin
Dublin
Trainer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior EHS Specialist
Louth
Louth
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Quality Engineer
Wexford
Wexford
Associate Quality Specialist
Tipperary
Tipperary
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Process Support Specialist
Carlow
Carlow
Operations Specialist
Louth
Louth
Quality Specialist
Tipperary
Tipperary
Quality Technician
Dublin
Dublin
Process Engineer
Limerick
Limerick
EHS Project Lead
Cavan
Cavan
Product Development Engineer
Galway
Galway
Maintenance Reliability Engineer
Tipperary
Tipperary
Maintenance Engineer
Cork
Cork
Aseptic Process Owner Lead
Dublin
Dublin
Quality Specialist (hybrid)
Tipperary
Tipperary
Senior Mechanical Engineer
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Principal R&D Engineer
Galway
Galway
Validation Engineer
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
QC Bioanalytical Analyst
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Project Engineer
Tipperary
Tipperary
Quality Validation Engineer
Limerick
Limerick
Process Support Specialist
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Senior Technical Writer
Dublin
Dublin
Electrical Engineer
Limerick
Limerick
Laboratory & Quality Manager
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
E&I Turnover Engineer
Carlow
Carlow
Facilities Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Associate Quality Operations
Limerick
Limerick
Project Engineer
Republic of Ireland
Republic of Ireland
Facilities Engineer
Carlow
Carlow
Engineering Shift Technician
Dublin
Dublin
R&D Director
Galway
Galway
Medical Device Director
Republic of Ireland
Republic of Ireland
QC Bioassay Analyst (shift)
Carlow
Carlow
Quality Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior R&D Manager/Director
Dublin
Dublin
Project Manager
Limerick
Limerick
Change Control Coordinator
Carlow
Carlow
Senior R&D Project Manager
Galway
Galway
CQV Lead
Tipperary
Tipperary
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Validation Engineer
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
Associate Global Trade Ops
Dublin
Dublin
Senior Engineering Manager
Limerick
Limerick
Engineering Business Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Quality Engineer
Galway
Galway
Process Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Process Engineer
Cork
Cork
Quality Systems Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Quality Systems Specialist
Dublin
Dublin
Automation Engineer
Cavan
Cavan
Associate Quality Specialist
Tipperary
Tipperary
E&I Turnover Engineer
Carlow
Carlow
Senior Quality Engineer
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Engineering Manager
Clare
Clare
Quality Engineer
Athlone
Athlone
Senior QC 24/7 Shift
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Senior Electronics Engineer
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Electrical Engineer
Cork
Cork
Packaging Engineer
Dublin
Dublin
Specialist Operations Engineer
Tipperary
Tipperary
Head of R&D
Galway
Galway
Senior Project Manager - Process Develop
Dublin South
Dublin South
Senior R&D Engineer
Clare
Clare
Senior Operations Manager
Tipperary
Tipperary
Process Development Engineer
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Manufacturing Engineer
Wexford
Wexford
Quality Systems Enginer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
EHS Systems Specialist
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Project Engineer
Clare
Clare
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Production Operator
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
Quality Manager
Dublin
Dublin
QC Laboratory Technician
Carlow
Carlow
Process Engineer (Shift)
Carlow
Carlow
Validation Engineer
Cork
Cork
Product Development Engineer
Galway
Galway
Microbiology Manager
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Manufacturing Shift Lead
Donegal
Donegal
Senior R&D Engineer
Galway
Galway
Distribution Centre Manager
Dublin
Dublin
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Principal Process Equipment Engineer
Dublin South
Dublin South
EHS Systems Specialist
Carlow
Carlow
C&Q Lead
Tipperary
Tipperary
Senior Regulatory Affairs
Galway
Galway
Process Support Specialist
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Associate Quality Control
Dublin South
Dublin South
Senior R&D Engineer
Clare
Clare
Qualified Person
Limerick
Limerick
Maintenance CMMS Engineer
Tipperary
Tipperary
Search Results for Qualified Person
Job Title. | Location | Salary | Actions |
QA Drug Substance Manufacture LeadOur client is a leading provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They are a global contract development and manufacturing company for biopharmaceuticals; they provide their clients with a world-leading open access technology platform. They enable their clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Due to an internal promotion, they are currently seeking to fill a critical role within the QA department. The QA Drug Substanc...Location: Louth, Republic of Ireland, |
Louth | Not Disclosed | |
Qualified PersonQualified Person Our client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously. Responsibilities Ensure manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation Ensure that biotech drug product batches are test...Location: Limerick, Limerick City, |
Limerick | 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
Valid XHTML - CSS