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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.
Sandwich is a town in the east of Kent in the South East region of England. Other towns and cities close to Sandwich include Canterbury, Ashford, Dover, Ramsgate and the revitalised resort town of Margate. The name of the town is probably of Saxon derivation meaning a “sandy place” rather than the well-known lunchtime food item. It is thought that the term “sandwich” came about when the 4th Earl of Sandwich asked for his lunchtime meat to be served between slices of bread so that he did not have to interrupt his gambling for lunch! Sandwich was one of the Cinque Ports which was a confederation maritime towns and villages in Kent and East Sussex dating back 1000 years that supplied fleet, military and transport services to the Monarchy prior to the creation of the Royal Navy. Although it was a major port in bygone days, Sandwich is now two miles from the sea and the reclaimed land is home to nature reserves and golf courses including Royal St George’s.
Pfizer, the multinational pharmaceuticals company, is a major employer in Sandwich and many well-known drugs including Viagra were developed in their laboratories in Sandwich. In addition to Pfizer, Discovery Park in Sandwich, the leading science park in Kent, is home to numerous Life Science, Biotech, Technology and R & D companies which employ a total of 3000 staff.