Quality assurance covers a variety of positions within a very wide range of businesses. Quality assurance is a systematic approach to managing the quality of products and the processes involved in their production. Therefore, most quality assurance jobs involve implementing and managing the quality systems employed by a business.
Quality assurance is a critical function for any production company, with a requirement to develop, establish and maintain high levels of professional standards in respect to food, pharmaceutical, biological and other related products.
Who sets the standards for Quality Assurance guidelines?
Depending on what the company produces and which markets they cater to, regulatory and quality authorities can vary tremendously. It could be GMP, GDP, GCP, GLP standards in compliance with MHRA, regulations in the Pharmaceutical and Biotechnology industries; BRC & HACCP in the Food sector; or ISO13485 for Medical Devices. Again, the quality assurance procedures and regulations will vary based upon the products and markets the company is operating in - this is why companies need specialist and dedicated quality assurance teams.
With respect to medicinal products, it is the World Health Organisation (WHO) who are responsible for setting global standards in quality assurance.
What does a QA specialist do?
A quality assurance specialist can have a very specialised yet diverse role, which may involve a range of responsibilities including auditing (internal / external), investigating customer complaints, generating PQRs (Product Quality Reports), managing CAPA investigations, validation etc. A Qualified Person / QP who takes ultimate responsibility for reviewing all QA activities and information prior to product release takes a crucial role in any pharmaceutical quality assurance team.
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