Job Title.	Location	Salary	Actions
Qualified Person We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Waterford. 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 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 cross-functional teams as Quality/Qualified Person representative. Participate in third party%2... Location: Waterford, Qualified Person	Waterford	Not Disclosed
QA Packaging Manager/QP QA Packaging Manager/QP Our client, a global healthcare company with operations based in Dublin are currently recruiting for a QA Packaging Manager/QP to join their team on a permanent basis. As QA Packaging Manager/QP you will be responsible for a range of GMP and product release support for secondary packaging activities which can include Quality batch documentation review and control, review and approval of controlled documents including batch records and SOPs, quality performance reporting, and support of investigations, complaints and projects. Responsibil... Location: Dublin, QA Packaging Manager/QP	Dublin	Not Disclosed
Qualified Person (QP) Qualified Person (QP) Our client a global healthcare organisation, are currently recruiting for a Qualified Person to join their team on a permanent basis. Responsibilities Perform QA/QP batch release as required to support operational business requirements (you will be required to be named on the site manufacturing licence as a QP and perform QP batch release as per current relevant EU guidelines) Provide technical expertise for all QA and compliance topics/issues as required Provide QA input into relevant Risk Management programmes within t... Location: Galway, Qualified Person (QP)	Galway	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.

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