How are the Development Opportunities as a GMP Expert?
The decision to work as a GMP expert is a clear decision for the future. A decision for the big world of the life sciences industry and thus for a wide range of development opportunities.
Many doors are open to the GMP expert. He or she is just as much in demand in small and medium-sized companies as in large, globally active corporations. It is hardly foreseeable that the demand for GMP experts will decrease. Quite the opposite: the need for experts with the certain GMP know-how will steadily increase.
Universities today already offer some basics on the topics of life sciences technology, pharmaceuticals and GMP. However, the actual knowledge, the background to GMP and the "How-To-Do" is best learned in practice – on the job, so to speak. The basics of technology and process knowledge are taught at university – the GMP knowledge is taught in practice. A lateral entry via an adequate apprenticeship is also possible. The common entry for university graduates is usually as a validation or qualification engineer.
A first decision has to be made: Do I go directly into industry and learn in-depth knowledge in a sub-area? Or do I go to a consulting house and learn about many areas and industries? It is important here to consider what opportunities there are to expand the required GMP knowledge.
The Experienced Validator
In the first two to three years, the GMP beginner gains most of his experience in validation projects. This enables him to work more and more diversely in a GMP project; for example, to work out risk analyses independently with the customer and to moderate these.
In the life sciences environment, validators and GMP experts are often called "consultants".
After two to three years of practical experience, it is not yet possible to provide comprehensive GMP consulting services completely on one's own. Nevertheless, this is again a time when many prospective GMP experts find themselves at a crossroads with regard to their professional future: Do I decide to go the service and consulting route, or do I go the manufacturing route? For one, the variety of consulting, the mobility and the diversity of tasks is the right thing. The other sees his future in the manufacturing environment of large-scale industry in a permanent job. Both have their charm, both offer opportunities and possibilities.
Working in Production Companies
Today, the topic of GMP is firmly established in the manufacturing life science industry, especially in pharmaceuticals, and is integrated into processes, organizations and corporate structures. Without GMP experts, nothing works anymore. On the technical side, qualifiers are also in demand in the manufacturing environment, as are planning engineers who deal with specific technical issues. In particular, with the question of what a GMP compliant machine or plant should look like.
However, technology and process are often separated, so that process validators and plant qualifiers are employed in different departments. The topic is certainly not exhausted in the pure validation and/or qualification. In manufacturing companies, especially the ongoing GMP operation plays an important role.
Standard Operation Procedures on specific tasks and topics are written, employees instructed or trained. Production deviations and/or changes to equipment and processes are processed, discussed, reviewed and approved. Visits to customers and authorities are planned and accompanied. Deficiencies are worked through and optimizations are driven forward within the scope of the given possibilities.
Particularly in larger pharmaceutical companies, separate departments have been formed around GMP, which are dedicated to the most diverse fields of activity, from qualification and validation tasks to quality assurance. For example, there are compliance departments that ensure comparable quality standards at the various global sites. Often, there is a separate group of auditors who specialize exclusively in regularly taking a close look at raw material suppliers. And let's not forget quality control, which is heavily affected by GMP requirements as part of routine analysis. GMP experts are specialists in their respective fields.
Smaller manufacturing companies cannot afford such specialized departments. GMP experts are deployed much more diversely here and perform several different tasks.
Work at the Service Provider
The biggest difference compared to manufacturing companies results from the diversity of the tasks to be performed. A broad spectrum of customers from a wide range of industries creates changing situations and new tasks – every project, every customer is different. And it offers the opportunity to build up and apply a broad range of practical and specialist knowledge. Once the know-how and expertise has been built up, it is exactly this broad practical experience that provides an advantage and also enables the confident application of what is known.
However, this attractive work situation places greater demands on flexibility in terms of location and time. This is because the plants and processes to be supported are located at the customer's site and therefore not always in the immediate neighborhood of a fixed place of work. Business trips are the order of the day, but also weekly trips or longer stays at home and abroad are common. This is certainly challenging in some phases of life, but it offers maximum variety and a wide range of tasks.
At the respective customer's site, the service provider not only inspects different plants or different processes, but also deals with a wide variety of GMP systems. These differ enormously depending on the product and the customer; documentation and regulatory requirements vary greatly. Knowledge of the most diverse regulations and country-specific requirements is just as essential as being responsive to the customer.
These and other qualities are required of the consulting service provider. Enthusiasm and the ability to take up the challenges of others, understand them and work out the necessary solutions are the qualities that lead to the GMP consultant having fun at work. GMP consultants enjoy interacting with people and the variety in their job. If you are looking for more of a routine, this may not be the right place for you.
If you decide to take the step into the GMP world and want to become a GMP expert, you should be aware that you are in demand as a specialist and knowledge carrier. This means: Learning is the basis of further development, the foundation of a career. Freely after Rudolf von Bennigsen-Förder: " Standing still is going backwards".
Thus, all developments are initially geared toward a specialist career. The development goes from specialist to highly experienced specialist to technical expert. GMP knowledge and practical experience are in the foreground.
But even as a GMP expert, it is possible to take on management tasks and start a management career. This usually starts with the role of project manager, who is responsible for projects or special task packages and guides others in the process. Typically, first individual employees, then smaller teams, up to leading a group, and in large companies up to managing an entire department.
A career in industrial companies often means the gradual assumption of personnel responsibility and management tasks while climbing the ladder in a hierarchical organizational structure.
A career with a consulting service provider is usually expressed in the management of a specialist department and an increasingly broadly oriented day-to-day work – with a lot of responsibility, but also with a lot of creative freedom. In addition to responsibility for excellence and profitability of completed projects, management tasks also include contacts in the professional world, (networking).
University graduates in engineering disciplines are highly in demand and sought after on the job market. This means that there are hardly any differences in terms of starting salaries and conditions in both the industry and the service provider.
In the course of development, the pharmaceutical industry naturally scores with attractive increases in compensation and add-ons, such as those offered by major global corporations. This is accompanied by a considerable increase in organizational integration and the focus on very specific tasks of the respective division. Service providers are generally more broadly oriented in this regard and, in the area of personnel development, focus on building up specialist knowledge and the company-wide deployment of young colleagues. Here, too, development is accompanied by a salary increase, although not to the same extent as in large-scale industry.
However, once a good level of expertise has been achieved and it is increasingly possible to work on one's own responsibility, the service providers' conditions follow suit. Performance-related bonus payments or a company car are common. Non-monetary aspects such as the possibility of mobile working or flexible working hours often make working for a consulting company much more attractive.