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Quality Assurance Sector Organisational Structure

The Quality function in a facility varies a lot dependent on the type of product produced, and the size of the facility.

In small companies that don't require Quality Assurance to be an intricate part of their day, they may only employ one Quality Person to look after the maintenance and upkeep of the internal Quality Systems. This person may also keep up to date on new legislation relevant to the industry. Companies like this could operate in the Connected Health space, or as Parallel Importers of pharmaceutical products. As the majority of the quality has been "assured" at source, these companies only require a sole Quality representative.

In a pharma or biotech company, things are vastly different. As QA must be monitored at every stage, there can be a large quality department. Any facility that produces and releases finished pharmaceutical products must have one or more Qualified Persons on site. These are the individual who are ultimately responsible for the batch of product. They sign off on each release, after having reviewed the dossier of quality documents pertaining to the batch. Once signed off, this batch can be traced back to the QP. The QP is thus personally responsible for the safety of the product. EU directive 2001/83/EC governs this process.

Medical Devices operate under the ISO 13485 quality standard, and people working in this area must be familiar with it. Yearly audits are carried out so that products produced conform to the standards required

Many of the industries above require Regulatory Affairs function, which usually work closely with QA and people often move from QA into Regulatory roles, when the opportunity arises.

In terms of organisational structure, a large Dept in a pharmaceutical could look something like this:

QA Assistant - QA Officer - QA Executive / Specialist - Quality Systems Specialist - Qualified Person - QA Manager - Quality Director

Quality Auditor Scientific Contract Supplier Quality Engineer Design Assurance Regulatory Affairs Director Manufacturing Engineer Regulatory Affairs Consultant Limerick City Galway Leinster Regulatory Affairs Officer Quality Engineer Sligo BD Manager Regulatory Affairs Executive Laboratory Project Manager Dublin West Validation Manager QA Manager Senior Quality Engineer Technical Support Meath Product Specialist Quality Systems Administator Design Engineer Roscommon Regulatory Affairs Manager Biopharmaceutical Technical Specialist Quality Assurance Technologist Regulatory Affairs Specialist Chemist Dublin City Centre Dublin North Contract Research and Development Engineer Healthcare Senior Research and Development Scientist Quality Manager Louth Cork Microbiology Validation Engineer Quality Control Supervisor Quality Control Manager Clare Validation Specialist QA Director Regulatory Affairs Medical Affairs Chemistry Validation Scientist Manufacturing and Technology Manager Kildare North Leinster Biomedical Engineer Lead Quality Engineer Pharmaceutical Laois Business Development Manager Longford New Product Development Engineer Medical Device Technical Support Specialist QA Analyst Quality Systems Engineer Engineering Dublin Greater Snr R and D Engineer Quality Systems Lead Project Manager Quality Specialist Engineering Manager QA Engineer Life Science Quality Systems Specialist EHS Engineer Republic of Ireland Life Science QA Specialist Limerick QA Supervisor QA Validation Specialist Carlow Dublin Mayo Galway City EHS Specialist Medical Director Connected Health Senior Research and Development Engineer QA RA Engineer Qualified Person Dublin South Clinical Research QE Manufacturing Engineer Biotechnician Snr Validation Engineer QA Executive Product Development Engineer Senior Regulatory Affairs Officer Engineering Quality Assurance Regulatory Affairs Clinical Research Senior Operations Engineer Biotechnology Regulatory Affairs