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Quality Assurance (QA) is a vital function within all Pharmaceutical and Medical Device companies. Job titles within the QA area can vary a great deal across different companies, with titles including QA Associate, QA Officer, QA Specialist and QA Scientist, then progressing to QA Manager, QA Lead etc. The QA terms, especially at junior-to-intermediate level, are often quite interchangeable.
The QA team is typically responsible for ensuring that the quality standards and systems followed in the manufacture of drugs is in compliance with Good Manufacturing Practice (GMP) and meets the specific quality standards laid out in the company’s Quality Management System (QMS). A QMS will include quality standards for internal audits, deviations, change controls, corrective actions, quality review reports, clean room monitoring, batch record review, and external documentation reviews.
A pharmaceutical QA professional’s responsibilities will include analysing the production process of pharmaceuticals, identifying areas where errors prevail, root cause analysis, observing every activity, monitoring the drugs being manufactured or packed for visible defects, testing the drugs (or at least interpreting the data from lab-based QC analysis), noting down observations gathered from the quality control process, and accepting or rejecting batches of drugs on the basis of samples (Batch Release). Quality Assurance teams will often be divided into different QA groups, with some more focused on batch record review while others are more involved in non conformance investigations and SOP (Standard Operating Procedure) updates.
Skills and Experience required for a career in Quality Assurance
- Science degree (this is not always essential)
- Experience gained in a GMP / ISO environment
- QA processes and systems
- Batch record processing
- Ability to multi-task
QA salaries can vary enormously depending on what specific duties the person will be undertaking. If the role is a relatively entry-level or administrative one, focused on batch review or entry and processing of QA documents / data, salaries could be in the £18k - £24k range. Salaries can then increase steadily once you start to specialise in a particular area, especially if this means getting involved in hosting / conducting internal or external audits, continuous improvement initiatives, team leadership, or training. QA offers a varied and interesting career path and you could earn up to £40k in a non-management role and significantly more than this once you are in a management-level position.
Stevenage is a town in Hertfordshire approximately 35 miles north of London. Although there is evidence of a Roman settlement, Stevenage grew very slowly over the centuries. However, in 1946 Stevenage was designated Britain’s first “New Town” which meant six neighbourhoods being developed to help resolve the UK’s post-war accommodation problems. Opened by the H.M. the Queen in 1959, Stevenage's pedestrianised town centre was the first traffic free shopping zone in Britain. From a business point of view, Stevenage has become a centre for Life Sciences thanks to the Stevenage Bioscience Catalyst which aims is to support the next generation of pharma and biotech companies by offering access to equipment and facilities and in so doing placing the UK bioscience sector at the forefront of worldwide biomedical innovation. More recently Stevenage has become famous for the annual rock and pop festival held at Knebworth.
Famous people born in Stevenage: Lewis Hamilton, F1 motor racing world champion and Ian Poulter, professional golfer