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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.
Maidenhead is a large town in the county of Berkshire in the South-East region of England approximately 30 miles from London, 13 from Reading and 32 from Oxford. Other major towns within easy reach of Maidenhead include Slough, Marlow, Henley on Thames and Windsor. Maidenhead enjoys excellent transport connections, being located on the A4 and M4 and having regular trains services into London which means that many residents commute into London, Slough, Reading and other towns.
The three main industries in Maidenhead and surrounding areas are pharmaceuticals & life science, visitor economy and digital technologies. Pharmaceutical and Life Science companies in the Maidenhead area include Abbvie, GSK and Johnson & Johnson, Abbott Laboratories, Biogen Idec, Covance, Inventiv Health, Sanofi Pasteur and Seqirus. Maidenhead lies on the “Silicon Corridor” which is home to numerous digital and other technology companies Telecommunications, Cyber Security, Data Centres and Cloud Computing, Big Data companies include Adobe, Hitachi, 3, LexMark and Fujitsu. The Royal Borough of Windsor and Maidenhead is home to many famous attractions including Windsor Castle, Legoland, Royal Ascot and Eton College. It also boasts many high-quality hotels and four restaurants with 3 Michelin stars. As a result, the visitor economy is a major employer in the area.
Famous people from Maidenhead: Geraldine James, actress and Hugh Lofting, author and creator of Dr Dolittle.