Qualification in the professional sense describes the personal capacity of an employee requiring specific competences depending on the individual workplace.
Professional qualifications are those qualifications that can be proven by documentary evidence, e.g. evidence of a formal qualification, proof of competence and/or professional experience. The recognition of professional qualifications is regulated by Directive 2005/36/EC of the European Parliament. Pharmaceutical regulations and the GMP Guidelines do not contain specific qualification requirements for personnel in pharmaceutical companies. An exception is the qualification requirement for the Qualified Person.
Due to the lack of precise requirements, personnel with “sufficient” professional qualification is often required by national regulations, e.g. the german AMWHV. The exact meaning of sufficient was left by the legislators to be decided separately for each individual case depending on the requirements. The particular requirements of an individual workplace are therefore decisive. This means that the nature and extent of the work to be carried out in the company determines the need for qualification and, as a result, the requirement profile for a workplace. The requirement profile for an employee should, in addition, be derived from his/her workplace and/or job description.
It is essential that companies are aware of their employees' qualifications and have defined requirement profiles because personnel may only be employed on the basis of their education, training and knowledge. The EU GMP Guidelines also require that the manufacturer only employs personnel with the necessary qualification (Part I, chapter 2.1). The requirement profile of the workplace and the qualification of the employee are, therefore, closely linked.
A qualification consists of theoretical knowledge, practical skills and the professional and operational experience of the employee, among other things. The extent to which a person can carry out professional tasks very much depends on their vocational training.
Vocational training has to impart the professional skills, knowledge and abilities which are essential for the exercise of a skilled occupation in a changing working environment as part of a well-regulated training course. This is meant to ensure consistency and high quality. It is important that the trainee acquires professional competence during the respective training course in order to pass the final examination. For this reason, professional experience gains great importance in conjunction with theoretical instruction. Professional competence is essentially the result of reflected work experience. A successful course of education has to combine knowledge and practical experience. Unfortunately, this is not the case in the majority of EU member states. They are more in favour of certified partial qualification and gaining work experience after acquiring a specific entry qualification.
A differentiated approach to the qualification requirements for personnel is required. On the one hand, the competences required for a particular workplace depend on the tasks and activities. On the other hand, the level of cooperation with others and/or the autonomy of the workplace require certain social and personal competences (cf. Figure 7). Along with the theoretical, and in most cases, practical knowledge (professional competence) acquired during vocational training, the know-how and experience gained in practice must also be applied. In addition, there is often a need for certain methodological abilities, especially the ability to correctly detect, assess and solve problems (methodological competence). In principle, these requirements also apply to managers. However, depending on the position of the manager in the hierarchy, leadership skills and personal as well as social competences have priority.
The tasks and activities that make up the workplace as well as the individual areas of decision-making and responsibility determine the requirement profile for an employee.
Because the requirements of the company and the general scientific, technical and legal requirements (framework conditions) change, requirement profiles must also be updated when necessary.
Michael Hiob, PhD
Ministry of Social Affairs, Schleswig-Holstein, Kiel, German