Blogs

So You Want To Be A QA Professional? 发布时间:2016-05-25

What is Quality Assurance?

Quality Assurance is the framework that ensures that the development and manufacture of products such as pharmaceutical, agrochemical and medical devices are performed in compliance with regulatory requirements. This is achieved through the development, implementation and continual improvement of systems. Independent assessment provides feedback on the robustness of such a system.

Why does it exist?

The development of regulations and guidelines covering the conduct of product development, inevitably led to the need for a degree of self-regulation to ensure that research and development was working within these regulations and guidelines.  Quality Assurance functions, with their roots in the early 1970s, have slowly evolved to ensure that product development was being properly conducted.  

In later years, many guidelines and regulations actually specified the requirement to have an independent audit function, which led to a rapid increase in their growth.

In addition to this, many companies now realise that QA Professionals are well suited to advise in the development of management and business systems.  This demands a wider range of skills from the QA Professional, than would initially seem necessary.  This would include a thorough knowledge of the product development process, excellent communication and influencing skills, problem solving skills and the ability to propose practical and pragmatic solutions.

What is a QA Professional?

The role of the QA Professional varies from company to company but there are three main aspects that can be considered as core:

  • Conduct of independent audits of the product development process to assure management of compliance with applicable regulations
  • Provision of expert and independent advice and consultation relating to interpretation of regulatory requirements, regulations and quality management systems
  • Integral part of the corporate risk management framework

Independent audits

There are a number of types of audits that are typically performed as part of the development and manufacturing process including internal facilities, systems and external partners (third party audits).

Advice and Consultation

This is a key aspect of a QA Professional role and they are often called upon to provide specific advice on interpreting a regulatory requirement or in how to handle a situation that may have arisen in the product development process, to ensure that it is brought back into compliance.  Because the QA professional works across many boundaries in the company and at differing levels, they will have a good breadth of understanding of the business.  As a consequence, they are often asked to act as consultants to process redesign teams, where they can share best practice seen in other parts of the organisation; identify potential gaps in a process where organisational boundaries are crossed and feedback on trends that may have been seen in audit findings.  The QA Professional may also be involved in leading or contributing to training courses within the company, on regulatory compliance or learnings from audits. 

An additional and increasingly important role of the QA Professional is as a facilitator of regulatory authority inspections i.e. inspections of the organisations involved in product development by external regulatory bodies such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).  In this capacity, the QA professional may be involved in helping prepare the organisation for inspection, by conducting a pre-inspection audit and/or providing training on what to expect in an inspection and how to manage it.  They may also be present during the inspection and act as the main company contact with the regulatory authority inspectors.

Risk Management and Corporate Governance

To fulfil financial, legal and ethical requirements for the management of companies all organisations will have a risk management and corporate governance framework. The role of the QA function in relation to this is variable but in many organisations they will be an integral part of this framework, in providing periodic summaries of audit outcomes and risk statements at Board level that identifies whether there are uncontrolled risks within the business.

Qualifications, Skills, Knowledge and Behaviours Required

The majority of QA Professionals in the industry have a life sciences degree, with some having a MSc or PhD.  However, most organisations are looking for individuals with some experience in Product Development.  In order to have the necessary credibility as an auditor, experience and maturity (not necessarily age, but personality) are essential.

In most companies, QA Professionals report at a high level so they are highly visible and what they do and say can have a significant impact.  Therefore, they have to be confident and competent otherwise they will lose their credibility.  As well as the obvious attention to detail, they should possess excellent interpersonal and communication skills, pragmatic problem-solving ability and have a sense of humour.  They also need to understand and fully appreciate how vulnerable and insecure auditees can feel.  A good QA Professional's first task should always be to put the auditee at ease.  This is an important skill and not everyone has the ability to achieve it.  QA Professionals also have to be very sure and confident about their work, as any mistake, however small, will result in criticism. 

It is important that QA Professionals are able to see the big picture; sometimes small issues can have major repercussions and the QA Professional must be able to quickly assess whether a non-compliance problem is important or not.  A good QA Professional must be able to put the problem into context and suggest pragmatic and practical solutions.  It is often easier to find a practical solution and to be able to communicate it effectively to those being audited, if the QA Professional has prior product development experience.

QA Professionals need to have a good knowledge of the regulations and guidelines.  Not many could recite all the regulations if asked, but they know where to obtain the information they need.  Most QA Professionals are good resource investigators i.e. they know how to find relevant information and ensure that they maintain an up-to- date knowledge of what is happening in the regulatory world.  The Internet has become an extremely important source of information.  In addition, professional organisations such as the RQA and the Drug Information Association (DIA) help to keep up to date with developments. 

Many QA Professionals operate internationally either in Europe or worldwide.  Depending on the size of the company and the area that you are working in the job may require a reasonable amount of an individuals time spent travelling.

Benefits of working in a QA Role

In describing benefits of any role it is difficult to generalise.  As what may be seen by one as a benefit may be a downside for someone else.  However, when talking to experienced QA Professionals these are the most common benefits that they list:

  • Gain an in-depth understanding of how complex organisations work.  This helps with future career aspirations and personal job satisfaction
  • Variety of role - through involvement in many different projects, processes and countries
  • Travel - able to see and experience many different cultures
  • Chance to make a difference/influence process - through audit activities, training and consultancy
  • Visibility within the organisation.  QA groups often report to the most senior management in the company.  As a result even junior auditors will get exposure to senior management at an early stage in their career.
  • Technical role but with a large emphasis on interpersonal skills. 
  • Autonomy - compared to a lot of roles there is a large degree of autonomy, where the QA Professional is generally able to set their own timelines for activities (within defined timeframes)
  • Opportunity to work with a wide range of people

Where can a career in QA take me?

The QA role provides an opportunity to learn about many aspects of product development and how each of the parts inter-link. This, combined with the huge variety of work that the QA Professional becomes involved in often leads to strong job satisfaction that keeps most people in the job for many years. For those looking for different career progression, prior experience as a QA Professional is generally viewed very positively by recruiters and people often go on to take up more senior roles in other company functions.

关于我们 | 我们的服务 | 联系我们

Copyright ; 2013 鼎晖思创 www.360cqa.com 版权所有
京ICP备13042479号