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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.
Swindon is a town in Wiltshire, in the South West region of England. It is located approximately 35 miles from both Bristol and Reading and 78 miles from London. Other major towns within reasonable distance include Oxford, Cheltenham and Salisbury. Swindon is on the main railway line from Bristol to London Paddington and, with an average journey time of only 1 hour to London, it is a major commuter town. Road connections are also good, thanks to the proximity of the M4 motorway. Although many residents commute to London, Bristol and other cities, a substantial number of major employers are located in Swindon including engineering firms such as Honda, BMW/Mini and Halcrow as well as W H Smith's HQ and distribution centre and pharmaceutical companies including Patheon, Catalent Pharma Solutions and Vygon (UK) Ltd. Swindon also has the head office of the National Trust, the UK Space Agency and national Research Councils including the Biotechnology and Biological Sciences Research Council.
Swindon has two major museums; the STEAM Museum which provides a detailed history of the Great Western Railway and the Museum of Computing, it is also home to the Bodleian Library's book depository, which contains 153 miles of bookshelves
Famous people from Swindon: Billie Piper; actress and Melinda Messenger; glamour model and TV presenter