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Project Manager
Limerick
Senior Manufacting Engineer
Republic of Ireland
Project Engineer
Tipperary
Recruitment Consultant
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Chemical Engineer
Tipperary
Head of R&D
Galway
R&D Manager
Galway
Senior R&D Engineer
Galway City
R&D Manager
Galway
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Project Engineer
Republic of Ireland
C&Q Lead
Tipperary
R&D Director
Galway
CQV Lead
Tipperary
R&D Manager
Galway
Trainer
Dublin
Analytical Chemist
Tipperary
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Dublin
Medical Device Director
Republic of Ireland
R&D Director
Galway
Process Engineer
Limerick
Project Engineer
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
Quality Specialist
Tipperary
Project Engineer
Limerick
Consultant




Search Results for Qualified Person
Job Title. Location Salary Actions

QA Director of Operations

QA 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,
QA Director of Operations
Louth Not Disclosed

Pharmaceutical Consultant RP/RPi

Pharmaceutical 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,
Pharmaceutical Consultant RP/RPi
United Kingdom Not Disclosed

Qualified Person - Pharmaceutical

QA 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,
Qualified Person - Pharmaceutical
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.
  • The QP must promote GMP through training and guidance internally.