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Search Results for Qualified Person
Job Title. Location Salary Actions

Qualified Person (QP)

Qualified Person (QP) Our client, a biopharmaceutical organisation are currently recruiting for a Qualified Person (QP) to join their team on a permanent basis. The successful candidate will have experience working with biologics and will have been on a licence previously. Responsibilities • Manage the batch disposition process to ensure timely release of products • Ensure the batch disposition process maintains compliance with site practices & regulatory requirements • Disposition of products & materials in accordance with directiv...

Location: Limerick,
Qualified Person (QP)
Limerick Not Disclosed

Qualified Person QP

Qualified Person QP Our client is a global manufacturer of biopharmaceutical products are currently recruiting for a Qualified Person (QP) to join their team on a permanent basis. AsQP, you will be responsible for ensuring that the process for the manufacture of drug product at is in compliance with cGMP and the associated regulatory requirements. Responsibilities • Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations • Provision of advice on all aspects of Reg...

Location: Carlow,
Qualified Person QP
Carlow Not Disclosed

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager
Dublin North Not Disclosed
Other Pharmaceutical Jobs
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QA Validation Manager Limerick Not Disclosed
Technical Sales Specialist (Service Department) Dublin Not Disclosed
Principal QA Validation Specialist 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.
  • The QP must promote GMP through training and guidance internally.