Manufacturers have to have quality systems for the design, manufacture, packaging, labelling and storage of medicines.
Working in quality assurance
Medicines have to be made by a registered process to a very tight specification to ensure that every batch is as pure as possible. 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 by Documentation Managers.
Pharmaceutical quality auditing
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.
Quality assurance managers
Quality assurance (QA) managers work closely with operations managers to ensure that there is overall control of the manufacture and packaging of the products. A QA specialist's role will include writing and revising control procedures, reviewing batch records for release of material, and completing internal, external and supplier audits to ensure a high level of quality awareness and compliance.
The Qualified Person (QP) is responsible for documentation sign off and product release of each individual batch of commercial or clinical trial material. For more information, see Qualified Person.
Good Manufacturing Practice (GMP) trainers
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.
Required skills and qualifications
Most roles will require you to have a relevant degree, often in pharmacy, chemistry, biology or a related discipline. A thorough knowledge of legal and administrative provisions, rules and directives and other regulatory requirements such as MHRA, are likely to be a priority in quality management. Experience is possibly the most sought-after attribute of any potential candidate, and roles with more responsibility and higher salaries will usually require more experience.
Other skills that are important:
- Excellent communication and team work skills
- Flexibility and adaptability
- Ability to work with minimum supervision, prioritise tasks and build cross-functional relationships.
- Computer literacy (Microsoft Office as a minimum)
As highlighted in the 'working in Quality Assurance' section above, there are various different roles within the field, which are available to those interested in career progression. It is also possible to move from Quality Assurance into regulatory science or even train as a Qualified Person. If you get a job working for a large company, there will be lots of opportunities to move into other areas within the organisation. There is also high demand for skilled and experienced quality personnel, making it a worthwhile area to build a career.
Salaries are dependent on a range of factors including organisation, location and level of responsibility. The average salary for a quality assurance manager in the UK is around £35,000. There are, however, a range of roles within Quality Assurance with salaries anywhere between £20,000 and £60,000+. Salaries at the top end of this scale are attainable for those with many years of experience in the sector.
For further information, take a look at the following career case studies within this area of the industry:
Last modified: 20 September 2023
Last reviewed: 20 September 2023