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Maintenance CMMS Engineer
Tipperary
Tipperary
Manufacturing Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Strategic Automation Lead
Waterford
Waterford
Senior R&D Manager/Director
Dublin
Dublin
Quality Systems Enginer
Dublin
Dublin
Project Engineer
Limerick
Limerick
Senior Technical Writer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Senior Quality Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Validation Engineer
Cork
Cork
Process Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior Electrical Engineer
Galway
Galway
QC Bioassay Analyst (shift)
Carlow
Carlow
Senior Electronics Engineer
Dublin
Dublin
Project Manager
Limerick
Limerick
Senior R&D Engineer
Clare
Clare
Quality Manager
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Senior HVAC Engineer
Dublin
Dublin
QC Chemistry Analyst (Shift)
Carlow
Carlow
QA Associate - Materials Management
Limerick
Limerick
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Quality Systems Manager
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Facilities Engineer
Carlow
Carlow
R&D Program Manager
Dublin
Dublin
R&D Manager
Galway
Galway
Product Development Engineer
Galway
Galway
Project Engineer
Limerick
Limerick
Senior Associate Quality Control
Dublin South
Dublin South
Suite Team Delivery Lead
Tipperary
Tipperary
Quality Validation Engineer
Limerick
Limerick
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Embedded Software Engineer
Athlone
Athlone
QC Laboratory Technician
Carlow
Carlow
Specialist Operations Engineer
Tipperary
Tipperary
EHS Project Lead
Cavan
Cavan
Senior Quality Engineer
Dublin
Dublin
Packaging Engineer
Dublin
Dublin
Project Engineer
Clare
Clare
Process Engineer (Shift)
Carlow
Carlow
Engineering Projects Lead
Carlow
Carlow
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Analytical Chemist
Tipperary
Tipperary
Associate Quality Specialist
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
Process Development Engineer
Galway
Galway
R&D Director
Galway
Galway
C&Q Lead
Tipperary
Tipperary
Electrical Engineer
Cork
Cork
Manufacturing Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
CQV Lead
Tipperary
Tipperary
EHS Systems Specialist
Carlow
Carlow
Quality Engineer
Galway
Galway
Senior Mechanical Engineer
Dublin
Dublin
Project Manager - Suite Lead
Tipperary
Tipperary
Biomedical Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Quality Engineer
Wexford
Wexford
Clinical Affairs Manager
Galway
Galway
Microbiology Manager
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Product Development Engineer
Galway
Galway
Change Control Coordinator
Carlow
Carlow
Senior Validation Engineer
Limerick
Limerick
Manufacturing Technician
Clare
Clare
Head of R&D
Galway
Galway
Principal QA Associate
Limerick
Limerick
Production Operator
Louth
Louth
Quality Operations Specialist
Dublin North
Dublin North
E&I Turnover Engineer
Carlow
Carlow
Facilities Engineer
Carlow
Carlow
Pharmaceutical Consultant RP/RPi
United Kingdom
United Kingdom
Senior Quality Engineer
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
Trainer
Dublin
Dublin
R&D Director
Galway
Galway
Electronic Design Engineer
Galway
Galway
Principal Process Equipment Engineer
Dublin South
Dublin South
Biomedical Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Director of Quality Engineering
Limerick
Limerick
Senior EHS Specialist
Louth
Louth
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
E&I Turnover Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Operations Specialist
Louth
Louth
Distribution Centre Manager
Dublin
Dublin
Process Engineer
Cork
Cork
Aseptic Process Owner Lead
Dublin
Dublin
Production Operator
Carlow
Carlow
Manufacturing Engineer
Limerick
Limerick
Process Support Specialist
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Quality Technician
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Validation Engineer
Dublin
Dublin
Senior Mechanical Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Process Engineer
Limerick
Limerick
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior Quality Engineer
Limerick
Limerick
R&D Director
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Program Manager
Cork
Cork
Vigilance Assessor
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Engineering Manager
Clare
Clare
QA Associate Specialist
Carlow
Carlow
Product Development Engineer
Galway
Galway
Quality Systems Specialist
Galway
Galway
Project Manager - R&D
Galway
Galway
Maintenance Reliability Engineer
Tipperary
Tipperary
Manufacturing Shift Lead
Donegal
Donegal
Senior Regulatory Affairs
Galway
Galway
Product Development Engineer
Galway
Galway
Manufacturing Engineer
Galway
Galway
Senior R&D Project Manager
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Manufacturing Engineer
Wexford
Wexford
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Project Engineer
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Senior R&D Engineer
Galway City
Galway City
Aseptic Process Lead
Carlow
Carlow
Quality Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Maintenance Engineer
Cork
Cork
Quality Technician
Dublin
Dublin
Validation Engineer
Limerick
Limerick
Project Process Engineer
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Manufacturing Specialist
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Associate Quality Specialist
Tipperary
Tipperary
Senior Process Enginer
Dublin South
Dublin South
Validation Engineer
Carlow
Carlow
Quality Technician
Carlow
Carlow
Production Operator
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Digital Lab Records Specialist
Tipperary
Tipperary
Senior Operations Manager
Tipperary
Tipperary
Associate Global Trade Ops
Dublin
Dublin
Senior QC 24/7 Shift
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
Automation Engineer
Cavan
Cavan
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Sourcing Specialist
Tipperary
Tipperary
Senior Engineering Manager
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Engineering Business Manager
Dublin
Dublin
Maintenance Engineer
Carlow
Carlow
Product Development Engineer
Dublin
Dublin
Senior QA Associate - Operations
Limerick
Limerick
R&D Manager
Galway
Galway
Planner/Scheduler
Cork
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Senior Validation Engineer
Dublin
Dublin
Recruitment Consultant
Wexford
Wexford
Project Engineer
Republic of Ireland
Republic of Ireland
Quality Manager - NPI
Dublin
Dublin
Quality Specialist
Tipperary
Tipperary
R&D Senior Program Manager
Galway
Galway
Senior QC Associate
Dublin
Dublin
Lab Systems Specialist
Tipperary
Tipperary
Quality Engineer
Athlone
Athlone
Quality Manager
Clare
Clare
Electrical Engineer
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Chemical Engineer
Tipperary
Tipperary
Client Project Manager
Louth
Louth
Search Results for Qualified Person
Job Title. | Location | Salary | Actions |
QA Director of OperationsQA Director of Operations Our client, a global biologics organisation are currently recruiting for a QA Director of Operations to join their team on a permanent basis. The QA Director will direct quality oversight of products manufactured and tested on site, from introduction through to product release. As QA Director, you will be responsible for all aspects of Quality activities associated with daily operations and future site and global strategic design. The QA Director will proactively identify and minimize product quality and compliance risks by establishing ...Location: Louth, |
Louth | Not Disclosed | |
Pharmaceutical Consultant RP/RPiPharmaceutical Consultant RP/RPi Our client a pharmaceutical consulting organisation are currently recruiting for a Pharmaceutical Consultant to join their team on a permanent basis. This role is based in the UK, the successful candidate must be able to commute to one of the following office Buckinghamshire, Hertfordshire or Cornwall. It is fully remote with occasional travel to client sites and ability to go to the office when required. A more detailed job description is available upon request. RP/RPi Responsibilities Ensuring that medicinal products have been QP released...Location: United Kingdom, |
United Kingdom | 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