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Search Results for Qualified Person
Job Title. Location Salary Actions

GMP Inspector

GMP Inspector Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation European Community Directives, Regulations and Guidance. These sites may include; • Manufacturers and distributors of medicinal products. • Manufacturers of investigational medicinal products. • Sites involved in ...

Location: Dublin,
GMP Inspector 		Dublin Not Disclosed

Qualified Person

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 client, 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. Here at our campus at Carrigtohill, Co. Cork, we employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide. Every second of every day, 365 days a year, a patient is diagnosed with the help our products through procedures such as ...

Location: Cork, Cork City,
Qualified Person 		Cork Not Disclosed

Operational Quality Manager / Qualified Person

We’re currently recruiting for an exciting opportunity with a pharmaceutical organization. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Ensures the batch disposition process maintains compliance with site practices & regulatory requirements. Support major investigations, ensuring all product deviations are closed prior to batch release. Reviews and approves Product Quality Reviews. Reviews and approves new and revised master manufacturing records. Participates in cros...

Location: Tipperary,
Operational Quality Manager / Qualified Person 		Tipperary Not Disclosed

Quality Director

Our client a global healthcare company are currently seeking a Quality Director to join their team The Quality Director is a key member of the organization who will lead strategic and operational performance of the Quality department. The Quality Director will be the most Senior position in Quality Department and successful candidate will be responsible for leading a team of managers and quality professionals Role/Responsibilities: Proactive contribution to discussions on quality topics and deliver quality improvements. Assuring site metrics are...

Location: Dublin,
Quality Director 		Dublin Not Disclosed
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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.