close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished

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 Systems Specialist QA Executive Carlow Roscommon Compliance Specialist Supply Chain Contract Dublin City Centre Quality Control Supervisor QE Manufacturing Engineer Validation Specialist Quality Systems Engineer Regulatory Affairs Consultant Medical Director Regulatory Affairs Quality Assurance Technologist QA Validation Specialist Quality Auditor Manufacturing and Technology Manager QC Analyst Regulatory Affairs Director Connaught Technical Support Specialist Kildare Scientific Leitrim Lead Quality Engineer Quality Systems Lead Westmeath Regulatory Affairs Officer Technical Support Validation Scientist Cork Senior Quality Engineer Biomedical Engineer Leinster Midlands Laois Engineering Engineering Manager Dublin North QA Manager QA Specialist Validation Engineer Life Science Cavan Life Science Offaly Dublin South Quality Control Manager Process Engineer QA RA Engineer Quality Manager Manufacturing Engineer Engineering Snr Validation Engineer Biopharmaceutical Regulatory Affairs Specialist Pharmaceutical Meath Regulatory Affairs Executive Microbiology EHS Engineer QA Engineer QA Supervisor Biotechnician Clinical Research Regulatory Affairs Manager Galway City Healthcare Senior Regulatory Affairs Officer Longford QA Director BD Manager Manufacturing Executive Quality Specialist Limerick Regulatory Affairs Clinical Research Qualified Person Supplier Quality Engineer Connected Health Quality Assurance Quality Engineer Medical Device Sligo Regulatory Affairs Limerick City Mayo Athlone Dublin West Technical Specialist Contract Validation Manager Louth Senior Operations Engineer EHS Specialist Biotechnology Dublin Greater Process Development Engineer Galway Chemistry Republic of Ireland Dublin Supply Chain Design Assurance Medical Affairs