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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.
Situated in the South West of England, Devon has two beautiful coastlines, two National Parks and five official areas of Outstanding Natural Beauty with sandy family friendly beaches.
Historic cities include Exeter and Plymouth, with its rich maritime heritage and its status as the regional capital for culture, Plymouth is one of the most dynamic and fascinating places to visit in Devon. With various large business parks, Plymouth Science Park currently has over 120 businesses. This is mainly made up of life science, digital technology and e-commerce. Annual turnover reaches £100 million, and varies from one-man start-ups to multi-national corporations.
Exeter exudes evidence of its centuries-old role as the spiritual and administrative heart of Devon. The city's Gothic cathedral presides over pockets of cobbled streets; medieval and Georgian buildings and fragments of the Roman city stretch out all around. Exeter as you’d expect from a city with a 2,000 year history, has stunning architecture and heritage visitor attractions. It is home to a large number of prestigious organisations who have chosen to base their national or regional headquarters there. Large companies include Perrigo, Actavis along with Devonport Royal Dockyard and its operator Babcock International Group; South West Water's parent Pennon Group; and Plymouth's Princess Yachts to name a few.