The medicine has to be made by a registered process to a very tight specification to ensure that every batch is as pure as possible and that it doesn’t contain any unexpected impurities. To achieve this, the process has to be documented at every stage and all processes must be carried out in line with Standard Operating Procedures (SOPs) that have been developed. This is the role of Documentation Managers.  

Pharmaceutical quality auditing plays a major role in quality management. The auditor must possess a blend of technical and personal skills in order to facilitate a common sense and flexible approach to many different pharmaceutical manufacturing and control situations. Trained Auditors perform audits of suppliers, and of contract manufacturers and packaging operations. Inspections are regularly carried out by Government agencies such as the American Food and Drug Administration (FDA) and there are regular internal company inspections. Trained auditors also ensure that systems are being maintained. 

A thorough knowledge of the legal and administrative provisions of EU rules and directives and other regulatory requirements such as FDA, are likely to be a priority requirements in quality management. 

Quality Assurance managers work closely with operations managers to ensure that there is overall control of the manufacture and packaging of the products. 

GMP trainers are important roles within any organisation. They often have to facilitate training at all levels of the organisation from Senior Management to Operator/Shop Floor level. They manage training programmes and competency assessments and need to be able to prepare and deliver training presentations, making them interactive and interesting.