By the Decree of the President of the Russian Federation No. 81 dated February 11, 2023, four employees of FSUE "Endopharm" were awarded the Medal of the Order of Merit for the Fatherland of the II degree: Deputy Director General for Legal Affairs Baranova Ekaterina Konstantinovna, Deputy Director General – Director of the Moscow Endocrine Plant manufacturing site Ovchinnikova Anastasia Anatolievna, Head of the First Department Semenova Natalia Ivanovna, Head of the H&S Department Matveev Gennadii Sergeevich.
State awards of the Russian Federation are the highest form of encouragement of citizens of the Russian Federation for services in the area of state-building, economics, science, in strengthening the legality, protecting health and life, protecting the rights and freedoms of citizens and other prominent services to the state.
At the beginning of 2020, Ekaterina Konstantinovna carried out extensive work on legal support (from the preparation of documents for receiving subsidies to commissioning) of the project for the reconstruction and construction of a workshop for the manufacture of sterile medicinal products in the form of solutions and lyophilizates in vials, as well as solutions for injection in single-dose syringes.
During the pandemic, the Enterprise launched a project on the organization of commercial manufacture of medical devices — medical face masks in the Pochep branch in the Bryansk region. Ekaterina Konstantinovna performed a tremendous amount of work on the legal support of the project, ranging from negotiations with counterparties to the conclusion and support of transactions, as well as preparation of legal opinions on the issues arising during project implementation.
During her work, Ekaterina Konstantinovna has strengthened legal protection and minimized legal and financial risks of the Enterprise.
During her work at the Enterprise, Anastasia Anatolievna has made a significant contribution to the organization of an effective pharmaceutical quality system that ensures compliance with international and local regulatory legal acts, guarantees safety, quality and effectiveness of the products released.
The result of Anastasia Anatolievna's consistent work was receipt by the Enterprise of a GMP certificate of the European Union, which is recognized in many countries of the world. It is applicable to the manufacture of medicinal products in the ampoule form and certifies that the process of manufacture, control, storage of medicinal products and other procedures at the Enterprise complies with the international GMP requirements.
Under the guidance of Anastasia Anatolievna, the accreditation of the testing laboratory of the quality control department in the Federal Service for Accreditation according to GOST ISO/IEC 17025-2019 was organized. In 2019, the competence of the Enterprise QCD testing laboratory was confirmed at the Russian and international level (certificate of accreditation No. RU.RA.21H019).
The implementation of all projects on the reconstruction and technical re-equipment of production facilities, laboratories and warehouse facilities for the introduction and manufacture of new dosage forms of socially significant medicinal products and active pharmaceutical ingredients takes place with direct involvement of Anastasia Anatolievna.
Over the years of work, Natalia Ivanovna has worked out and adjusted the work of the first department in accordance with the requirements of the Law of the Russian Federation "On State Secrets" No. 5485-1 dated 21/07/1993 and the instructions for ensuring secrecy in the Russian Federation dated 05.01.2004. She initiated and brought the name of the special department as the first department into compliance.
To ensure timely, complete and high-quality fulfillment of tasks by employees, Natalia Ivanovna organized and planned measures to control access to the preservation of state secrets, thereby ensuring effective management of the information security system at the Enterprise. Natalia Ivanovna organized work of the departments of FSUE "Endopharm" with information containing details classified as state and official secrets in respect to the possibility of conducting closed works, coordination of strategic and technical tasks, as well as work to prevent secret information leakage.
At the moment, Natalia Ivanovna conducts secret paperwork in many areas: development, registration and implementation of manufacture of medicinal products; performing research and development works; development of special medicinal products under instructions of federal executive authorities authorized in the field of national defense and state security, including research, development and engineering works containing information constituting a state secret in special contracts.
Jointly with the quality service, Gennadii Sergeevich directly participated in the work on the certification of the Enterprise for compliance with the requirements of the current national rules of good manufacturing practice (GMP), performing tasks on the development of internal procedures and testing in clean areas/premises, which, among other things, enabled the Enterprise to receive a certificate of compliance with the pharmaceutical quality system according to GOST R 52249 "Good manufacturing practice for medicinal products (GMP)" in 2011.
Gennadii Sergeevich has developed and implemented the occupational health and safety management system at the Enterprise with more than 1,500 employees.
Having extensive experience in the development and implementation of best technologies and practices for the prevention of injuries, formation of safety culture, motivation of employees to comply with safe working conditions, Gennadii Sergeevich ensures monitoring of working conditions at the workplaces, preparation of proposals and implementation of protective measures against the effects of hazardous and harmful production factors, reporting about accidents, analysis of their causes, conducts work on the prevention of accidents with Enterprise employees and the development of measures to prevent them, which contributes to timely adoption of corrective and preventive actions aimed at continuous improvement and enhancement of the industrial safety management system.
The management and personnel of FSUE "Endopharm" congratulate their colleagues with well-deserved honours. High assessment of the activities of the employees of FSUE "Endopharm" confirms the professionalism of the Enterprise personnel and serves as an incentive to new victories and achievements.
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