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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