2.A Place of work and job descriptions

Here you will find answers to the following questions:

  • What must be included in a job description?

The tasks of staff in management or responsible positions, including the Qualified Person(s), should be recorded in writing in descriptions of the place of work. The requirements of descriptions of the place of work are established uniformly for all of Europe in Article 7(2) of Directive 2003/94/EC. The hierarchical relationships between places of work must be described in an organisational chart. Organisational charts and descriptions of places of work must be approved in accordance with internal procedures.

As well as tasks, staff must also be assigned sufficient authorities to be able to fulfil their responsibility. In addition to this, the EU GMP Guideline expects gaps or unjustified overlaps in the definition of fields of responsibility to be avoided.

By nature, the place of work is locally contained and should fulfil an exclusive number of functions. The description of the place of work defines the responsibilities of an employee in terms of the tasks and responsibilities given to him at a place of work assigned to him. It should be available in written form and must be adapted to changing operating circumstances as required.

In many plants, the managing staff in particular are responsible for several places of work, e.g. one employee might simultaneously be the head of quality control and the security manager, or he might be the managing director and head of production or might perform the functions of head of warehousing and head of sales in a combination of functions.

A job description summarises the tasks of an employee for a particular job. As the job holder, an employee can perform several functions at different locations. The job descriptions for the staff in management positions, in particular those of the public law functionaries, must be formulated in detail and authorised by the board of management. The job descriptions of other staff can be recorded in the form of group job descriptions.

The following diagram (see figure 2.A-1) shows the contents of a job description:

Figure 2.A-1 Contents of a job description  

Company name/company logo
Job description valid from: Page x of y

Name of the job

E.g. "Head of Research and Development Department" or "Head of Production"

Name of the employee and internal abbreviation, if used

E.g.: "Hans Meier (HME)"

Address

Address of the job, or personnel number, telephone

Name of department

This is where the relevant plant unit assignment should be specified, according to the position within the company organisational chart, e.g. "Liquids manufacturing department II" or "Quality control department, microbiology sub-department".

Deputy of the job holder

The deputy stands in for the job holder when they are on vacation or absent due to illness or for business-related reasons, such as training or business trips. If several deputies are named, there must be a clear definition of which of these deputies is responsible for which areas/functions, or in which order the deputies should assume their role.

Superior

Here, a distinction should be made between personnel supervision and technical supervision. Personnel supervision and technical supervision can be undertaken as one job or by several superiors.

Personnel supervision, usually the personnel department, regulates all queries associated with the job holder's employment relationship, such as salary, vacation requests or internal relocation applications and, to this extent, has authority over the job holder.

Technical supervision monitors that the job holder is executing his tasks in a technically correct manner. In hierarchically organised plants, technical supervision is undertaken by the direct superior in the line management.

For drugs law functionaries, such as the head of production, the head of quality control and the head of sales, please note that they are not bound by instructions in the context of their public law tasks.

Authority of the job holder to instruct

The authority of the job holder over staff can be taken from the hierarchy of the company organisational chart. In this case, the job holder has authority over the staff on the line below him. However, interdepartmental authorities are also possible, e.g. the authority of the head of production to instruct warehouse staff in terms of drugs law, if the warehouse is not under the control of the production department, but the sales or administration department, for example.Authorities to instruct in matrix or team organisations, as well as for particular projects, must also be specified here.

Authorisations

These include:

  • Authority to sign, e.g. "signed on behalf of second person" or "signed ppa"
  • Power of disposal over materials and funds, also budget responsibility

Requirements profile

Description of the expected, personal requirements (e.g. education) and the minimum qualification (professional, personal, social competence), to be fulfilled for this job.

Job targets

The targets to be achieved by the job holder, e.g.: "as head of production, is responsible for the proper production of the drugs in compliance with the pertinent legal provisions and guarantees a cost-effective production workflow." A job target is the description of a verifiable status, which can be deduced as a result of the decisions expected of the job holder.

Detailed description of the tasks/activities

Here, there should be a description of the tasks, in particular those that are of significant importance for the organisation and are to be continuously fulfilled. It should actually be possible to evaluate the tasks shown. In the detailed description of the tasks, a distinction should be made between the job holder's responsibility to execute, cooperate and inform.

The responsibility to execute exists for original tasks of the job holder, such as monitoring of proper storage by the head of production, assessment of drugs risks by the drug safety manager or validation of analytical methods by the head of quality control. In these cases, the job holder is personally responsible for achieving the targets.

The responsibility to cooperate relates to tasks in which the job holder should provide assistance to others, e.g. the cooperation of the head of production in production planning, the cooperation of the head of quality control in the auditing of contractors or the cooperation of the head of engineering in the qualification of machines. In these cases, the job holder fulfils a service function by helping other staff to achieve their targets.

The responsibility to inform includes the comprehensive and timely transfer of information that accrues in the job holder's task area, and is which is required by others to fulfil their tasks.

In this sense, for example, the head of quality control determines the personnel and material costs per analysis for the administration department's budget planning, or the head of warehousing informs the sales department of the goods stock, or regulatory affairs department informs the head of production of production related contents of the registration dossier.

If possible, the tasks/activities should also be quantified, e.g. as "frequent" with 10% activity scope, "significant" with > 25%, "predominant" with > 50%, and "complete" with > 90%.

Special tasks

Special tasks can be short-term tasks in excess of the employee's regular obligations, e.g. carrying out activities within projects or performing special tasks on the instructions of the superior.

Personal obligations

This could be, e.g.:

  • regular undertaking of the health check by the company doctor, incl. reporting of infection diseases
  • participation in further training measures in the context of the in-house training plan
  • provision of own car for business trips

Reviewed by/on

The accuracy and completeness of the job description should be reviewed by the superior

Approved by/on

The job description for management staff should be authorised by the board of management. For all other employees, approval can be granted by the technical- or personnel supervision.

Acceptance of the job holder/on

Of course, the job holder must also document his acceptance of the job description by means of a signature. Usually, the job holder receives a copy of this.

Job descriptions are an important requirement for the introduction and maintenance of a pharmaceutical quality assurance system. The quality of drugs depends crucially on the quality of the organisation and the management. Each employee must know which targets he is expected to achieve, which tasks and authorities he has and for what he is responsible.

A good job description therefore contains clearly defined competencies, tasks and targets of the individual jobs. The job description is not a bureaucratic formalism and should in no way inhibit the employees' independent initiative. Nor does the definition of tasks and competencies exclude the possibility of collaboration within the team, even across departmental boundaries. Rather, the job description should create clear fields of action and responsibility and thus increase the employees' motivation and willingness to work.

From his job description, the job holder must be able to recognise his place in the overall organisation. He must be able to delimit his responsibilities from other areas. He and his superiors must have a consistent concept of the type and scope of the tasks assigned to him.

A job description forms a good basis for future personnel recruitment measures or personnel deployment planning. For the employees, the job description allows for a current determination of their position in terms of their personal career plan. For all specialised superiors, job descriptions are the basis for defining learning objectives for training course planning and execution.

In order for a job description to retain its practical orientation, it should be composed by the current job holder and reviewed by their superior. The job holder is usually able to describe his tasks in the most detail. In addition, this procedure requires the superior and employee to communicate with each other from the outset and to agree on the tasks and targets of the job. Of course, the superior also reserves the right to explicitly record unpopular tasks in the job description. On request by the employee, the personnel council or works council can be involved in compiling the description of the place of work.

Summary

Job descriptions define the tasks, competencies and responsibilities of an employee. They must be available in written and up-to-date form, and must be approved.