Qualified Person (QP)
A Qualified Person (QP) is a key figure in the quality assurance of medicines produced by pharmaceutical companies.
Working as a Qualified Person
The Qualified Persons within a pharmaceutical company have a crucially important role in that they ensure the safe control of medicines. They have extensive training and an in depth understanding of the industry in order to qualify them for the role, where they have the legal responsibility to certify batches of medicines prior to release. This is known as 'batch release' and refers to release to be used in clinical trials or release to be placed on the market. They are essentially within quality assurance of medicines and take responsibility for ensuring good manufacturing practice is in place.
Required skills and qualifications
In the UK, pharmacists, chemists, biologists and other scientists in relevant fields can become QP's. Specific knowledge and experience are essential, along with a nomination from a relevant body.
Qualified Persons must be nominated by certain regulatory bodies to certify that they are eligible for the role. One body that does this is the Royal Pharmaceutical Society. Nominations are subsequently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) – they have the final say as to who can be named a Qualified Person within pharmaceutical manufacture. The most important attributes for a QP are:
- Thorough understanding of pharmaceutical law, quality management systems and the professional duties of a QP
- Mathematical and statistical skills
- Medicinal chemistry and technical pharmaceutical knowledge
- A strong understanding of the manufacture and supply chain
- Leadership skills
- The ability to cope well under pressure, make confident judgements and act decisively when things go wrong
In terms of specific qualifications that are required, a pharmacy degree can provide the initial knowledge to set you up for the role. Additional training courses are available to those who are interested in becoming a QP.
The career prospects open to a QP are vast and cover many areas of the pharmaceutical industry, as well as other industries. You could work in other areas of regulatory affairs or quality assurance as well as production, marketing, project management and R&D. There are plenty of options and opportunities to keep learning and developing.
A QP is in a position of huge responsibility within pharmaceutical manufacture. As a result, the average salary in the UK is approximately £57,000, but this can vary. Some QP's will earn £40,000 per year and some as much as £90,000+ depending on the size and location of the company, and the level of responsibility and experience of the QP.
For more information, take a look at this case study of a Qualified Person.
Last modified: 20 September 2023
Last reviewed: 20 September 2023