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Search Results for Qualified Person
Job Title. Location Salary Actions

QA Team Lead & QP

QA Team Lead & QP Our client, a global pharmaceutical organisation are currently recruiting for a QA Team Lead to join their team on a permanent basis. The suitable candidate will also be an experienced QP. Responsibilities • Manage the day to day administration of all required Quality Management System elements assigned in line with the appropriate current Quality policies/procedures and appropriate quality regulations • Perform QA/QP batch release as required to support operational business requirements (the job holder is required to be named on th...

Location: Galway,
QA Team Lead & QP
Galway Not Disclosed

QA Manager

Our client is a company with a focus on the development and manufacture of generic pharmaceutical products. A key hire has opened up due to expansion. Real opportunities exist with this organization for the right candidate. Some travel is included with role. Previous experience of generics is essential for this post. A superb salary and working environment is on offer. RESPONSIBILITIES 1. Management of QA team a. Supervise all day-to-day activities of Irish QA team b. Recruit new staff as required c. Assign tasks to each QA team member and monitor performance levels. d. Report on reg...

Location: Dublin North,
QA Manager
Dublin North Not Disclosed

Senior Qualified Person

Senior Qualified Person Our client, a global biopharmaceutical company are currently recruiting for a Senior Qualified Person to join their team on a permanent basis. The ideal candidate for this role will have experience as a named QP on a manufacturing license. This role is based in Cork, and has excellent career progression opportunities. Responsibilities • Responsible for certifying batches prior to release to filling site • Ensure that the batch and its manufacture comply with GDP, GMP, Marketing authorization, IMPD & Import Licenses dependin...

Location: Cork,
Senior Qualified Person
Cork Not Disclosed

QA Manager

Our client is seeking a QA Manager to fill an existing position in West Dublin. They are a pharma facility with a strong, inclusive culture and some very interesting projects on the horizon. Responsibilities: • Ensuring GMP and GLP on site • Review and approval of QMS related documentation for compliance with GMP • Preparation for and participation in both customer and regulatory inspections • Preparation of Annual PQRs • Process Deviation Report management including implementation of effective corrective actions • Managing Custo...

Location: Dublin West,
QA Manager
Dublin West Not Disclosed
Other Pharmaceutical Jobs
Job Title Location Salary Actions
R&D Production Team Leader (Generics) Dublin Not Disclosed
Validation Engineer Limerick Not Disclosed
Senior Application Technologist (Bakery) Kildare 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.
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