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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.
Welwyn Garden City
Welwyn Garden City is a town in Hertfordshire in the East of England region. It is located approximately 25 miles north of central London. Other towns and cities nearby include Luton which is 15 miles away, Watford 22 miles away, Hemel Hempstead 15 miles and Stevenage 10 miles. Welwyn Garden City was the second garden city in England and one of the first new towns. Welwyn Garden City's proximity to London and excellent transport links make it a convenient commuter town. Direct trains run to both Kings Cross and Moorgate stations in London as well as Cambridge and Peterborough.
Owned by the University of Hertfordshire, BioPark is a research and development facility providing specialist laboratories and conference facilities for bioscience, health technology, biopharmaceutical, contract research, medical technology and other biomedical businesses. The Tesco HQ is located in Welwyn Garden City.
Famous people from Welwyn Garden City: Nick Faldo, Golfer and Alesha Dixon, singer