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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.
Dunfermline is the second largest town in Fife, Scotland and is located approximately 3 miles from the northern shore of the Firth of Forth, 40 miles from Glasgow, 17 from Edinburgh and also 17 from Stirling. Dunfermline was the capital of Scotland for over 500 years. Dunfermline Abbey, which was founded in the 12th century by Queen Margaret, is the most famous ancient building in the town and its graveyard was been the burial place of 11 of Scotland's kings and queens up to including Robert The Bruce in 1329. Other ancient buildings include the Royal Palace, Abbot House and St Margaret's Cave.
There are numerous golf course within easy reach of Dunfermline, including the world famous St Andrew’s golf course which is only 40 miles away. The majority of employment in Dunfermline is in the service sector, with significant employers Sky UK, Amazon and Best Western. The Carnegie campus just outside the city is home to a growing number of technology, medical device and other hi-tech companies.
Famous people born in Dunfermline: Iain Banks, novelist and Barbara Dickson, singer/songwriter