The staffing problem in the pharmaceutical industry remains relevant, particularly concerning the preparation of specialists for high-tech production. It is the personnel that can either hinder the industry’s development or contribute to its rapid growth. Irina Spichak, Executive Director of the Eurasian Academy of Good Practices, Doctor of Pharmaceutical Sciences, and Professor, discusses the opportunities, skills, and prospects offered by additional professional education.
Irina, how do you assess the current staffing situation in the pharmaceutical industry?
Today, we can observe several key trends. Firstly, the shortage of highly qualified specialists reaches 30%, which means that approximately one in four positions within a company may be filled by an employee lacking sufficient competencies.
Secondly, the staffing shortage is compounded by a competency gap. The pharmaceutical industry is developing at an astonishing pace, with new companies emerging, technologies becoming more complex, and modern equipment being implemented. Against this backdrop, skills and knowledge quickly become outdated.
Thirdly, many key positions are held by older employees who will soon exit the labor market. A younger generation is to replace them. It takes about a year for a university graduate to adapt to working in pharmaceutical sector. However, as HR managers note, modern young people often lose motivation and interest in chosen specialty, with approximately one-third of young specialists leaving their companies.
What types of specialists do you think will be in short supply in pharmaceutical companies?
As technology evolves, we are witnessing a peculiar evolution of competencies. It is already clear that some will diminish due to automation and digitalization, while others will grow, particularly concerning technical and engineering skills, competencies in quality assurance and control, process technology and validation, R&D, and technology transfer. New competencies will emerge, including management of large databases, artificial intelligence, digital technologies, cybersecurity, and many others.
Therefore, new professions should be formed. There will be a tendency towards interdisciplinary merging, leading to the emergence of so-called “hybrid” specialists, such as IT specialists in pharmaceutical production, digital biotechnologists, and others.
The Eurasian Academy of Good Practices is engaged in postgraduate professional training for the pharmaceutical industry specialists, including foreign experts. Which programs are currently most in-demand?
The Academy is a leading educational center for training specialists working in the pharmaceutical industry. More than 530 companies and organizations train their employees on the Academy’s platform. Over the past five years, more than 19,000 specialists have participated in training as listeners, and over 240 educational programs have been implemented on the most relevant industry issues.
The main areas of educational programs include Good Pharmaceutical Practices (GMP, GDP, GEP), training auditors for pharmaceutical companies, biotechnological production of drugs, drug development and registration, technology transfer, digitalization of processes, and many more.
When developing the educational program plan, we primarily focus on industry demands and trends that generate interest as well as the most controversy. All programs aim to develop professional competencies at four levels: basic, advanced, proficient, and expert.
All speakers at our Academy are recognized industry experts, including international specialists, with extensive experience in pharmaceutical enterprises and pharmaceutical inspection. Up to 60% of the total hours in the programs are dedicated to practical cases, situational tasks based on real production challenges, and business games, including the use of the simulation virtual complex “Pharmaceutical VR Factory,” etc.
We know that industry specialists are interested in the Academy’s training inspections. What are the unique aspects of auditor training at production sites?
Yes, training inspections are a unique development of our Academy. We understand that the pharmaceutical industry has successfully overcome the establishment of GMP practices in production, and it seems that we can all breathe easy. However, the next step is improving to a mature level. This is highlighted by the increasingly stringent regulatory checks requirements. Only well-prepared specialists, who have undergone an in-depth immersion in the auditing process of their production site jointly with highly qualified experts, can achieve this.
The audit methodology includes a continuous dialogue between auditing instructors and listeners, discussing current regulatory requirements and recommendations, thorough documentation of all audit stages, including assessment and in-depth analysis of any discrepancies noted and the development of CAPA (Corrective and Preventive Actions).
During the week of training listeners receive not only a substantial amount of information, but a critical perspective on their enterprise’s compliance with GMP requirements, answers to emerging questions, and comprehensive practical training on conducting self-inspections.
Innovation has always been a component in the pharmaceutical industry. How is this reflected in educational programs?
The primary task of additional professional education is advance training. To see and implement innovations in their work, specialists must initially acquire these innovative competencies. Therefore, the educational programs at the Academy always incorporate an innovation component, commonly based on the experiences of leading companies and speakers-innovators.
This is significantly supported by innovative projects, presented at the international contest “GxP-Profi,” conducted by the Eurasian Academy of Good Practices in collaboration with the Ministry of Industry and Trade of the Russian Federation and the Eurasian Economic Commission (EEC). For several years, we have observed the remarkable innovations proposed by creatively thinking specialists who strive for quality improvement in pharmaceutical companies. The best projects form the basis of our educational cases.
