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Snr Associate QC
Dublin
Dublin
Snr Associate QC
Dublin
Dublin
QC Manager-chemistry (LOA007664 )
Limerick
Limerick
Sr Quality Engineer
Galway
Galway
Operations Manager
Galway
Galway
Clinical Project Manager
Republic of Ireland
Republic of Ireland
Manager/Senior Manager QA Operations
Limerick
Limerick
Snr Quality Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Project Engineer - Toolroom Set Up
Limerick
Limerick
Process Engineer
Limerick
Limerick
Principal R&D Engineer
Dublin Greater
Dublin Greater
GMP Inspector
Dublin
Dublin
Clinical Trials Manager
Dublin
Dublin
Quality Engineer
Cork
Cork
Associate Director Quality Systems
Limerick
Limerick
R&D Technical Lead
Limerick
Limerick
Senior Process Engineer
Dublin South
Dublin South
Process Engineer
Limerick
Limerick
Commissioning and Qualification Lead
Dublin South
Dublin South
NPI Quality Manager
Dublin
Dublin
Senior Project Engineer
Louth
Louth
Senior Electronic Engineer
Limerick
Limerick
Head of Medical
Dublin
Dublin
Electro-Mechanical Shift Technician
Dublin North
Dublin North
Senior R&D Engineer
Dublin
Dublin
Senior Project Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Analytical Services Manager
Tipperary
Tipperary
Senior Tech Transfer Lead
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
QA Validation Manager LO(A008122)
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
QC Microbiology (Senior)
Dublin
Dublin
S&OP Director
Cork
Cork
Senior GMP Auditor
Republic of Ireland
Republic of Ireland
Commissioning Engineer (Biopharma)
Kilkenny
Kilkenny
Commissioning & Qualification Engine
Netherlands
Netherlands
Optimisation Leader
Cork
Cork
Engineering Manager
Dublin
Dublin
Quality Engineer
Limerick
Limerick
Senior QA Specialist
Dublin
Dublin
R&D Scientist (Chemistry)
Wexford
Wexford
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Limerick
Limerick
QC Associate Manager (LO A007956)
Limerick
Limerick
Principal Material Scientist
Dublin
Dublin
Supply Chain Manager
Dublin
Dublin
Injection Moulding Engineer
Limerick
Limerick
Senior Process Engineer
Dublin South
Dublin South
Senior QC Microbiology
Dublin
Dublin
Associate Quality Engineer
Galway City
Galway City
Process Engineer
Dublin North
Dublin North
Mechanical Engineer
Dublin
Dublin
QA Senior Associate
Dublin
Dublin
Principal Regulatory Lead
Galway
Galway
R&D Manager
Galway
Galway
Associate Director Warehouse & Logis
Limerick
Limerick
Automation Engineer
Kilkenny
Kilkenny
Automation Engineer
Cork
Cork
VP of R&D
Galway
Galway
Packaging Engineer
Galway
Galway
Search Results for Qualified Person
Job Title. | Location | Salary | Actions |
Manager/Senior Manager QA OperationsManager/Senior Manager QA Operations Our client, a growing Biopharma organisation are currently recruiting for a Manager/Senior Manager QA Operations to join their team on permanent basis. As Manager/Senior Manager QA Operations you will beresponsible for overseeing a QA team and their projects. Responsibilities Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions; Master records, executed records, failure investigations Change Controls, SOPs, Validation protocols and summary re...Location: Limerick, |
Limerick | Not Disclosed |
Other Pharmaceutical Jobs
Job Title | Location | Salary | Actions |
QA Validation Manager LO(A008122) | Limerick | Not Disclosed | |
Director of Clinical Pharmacology (Infectious Diseases) | Dublin | Not Disclosed | |
Commissioning Engineer (Biopharma) | Kilkenny | 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.
Scientist Dublin Validation Engineer Packaging Engineer Microbiology Mayo Sales and Marketing Product Development Engineer Cork Laboratory Scientist Connected Health Sales and Marketing Engineering Quality Control Clinical Research Pharmaceutical Supply Chain PhD Medical Device Academic Quality Engineering Scientific Life Science Chemistry Medical Affairs Project Manager Manufacturing Executive Academic Limerick Diagnostics Allied Healthcare Biopharmaceutical Quality Assurance IT Biotechnology Pharma Sales Cork City Supply Chain
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 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 © 2020 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






