от компании (организации): ООО MSD Pharmaceuticals в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Производство"
с заработной платой: по договоренности
Вакансия № 21251157 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 20 августа 2024 года.
Дата обновления вакансии № 21251157 на сайте Работа в Москве и Московской области (МО, Подмосковье): Вторник, 24 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21251157 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Quality Systems and Compliance Director (GMP Director)
Job Purpose:
GMP Director is responsible for end-to-end management of Russian / EAEU GMP inspections process of foreign manufacturing sites in accordance with regulatory strategy.
Job responsibilities:
- Organize and coordinate the work of GMP team. Ensure effective team management.
- Plan and execute GMP inspections of medicinal products manufacturers (over 30 active sites) in accordance with the regulatory strategy. Coordinate and control the timelines of GMP certification of medicinal products manufacturers and maintain the relevance of existing GMP certificates.
- Manage inspection applications preparation by the team.
- Manage and participate in inspection readiness activities in collaboration with the Company’s headquarters, as well as with other subdivisions of the Company.
- Support manufacturing sites before/during/after the inspection.
- Participate in CAPA development. Manage CAPA related activities / inspection response submission.
- Ensure effective interaction on the issues of compliance with GMP requirements of the RF and the EAEU with the Company’s headquarters, as well as with other subdivisions of the Company.
- Manage transition to certification in accordance with the EAEU requirements
- Establish and maintain cooperation with regulatory authorities.
- Participate in strategic planning of Regulatory affairs department activities.
- Provide the necessary regulatory support in the field of GMP to local projects, including the projects related to business development.
- Take part in the development of standard operating procedures of the regulatory affairs department.
- Monitor changes in the legislation of the RF and the EAEU in the field of MP circulation, GMP inspecting, if necessary, develop a preventive strategy to minimize the impact of these changes on regulatory activities.
- Conduct a periodic assessment of the work and professional qualities of direct subordinates in accordance with the procedure for assessing professional development and other types of assessment adopted by the Company.
Requirements to the candidate:
- At least 8 years of experience in regulatory affairs or quality assurance in an international pharmaceutical company.
- At least 5 years of experience in supporting Russian GMP inspections.
- Experience of work in cross-functional projects, including business-projects.
- Ability to timely assimilate, analyze and apply significant amounts of information, including information about medicinal products, manufacturing processes, quality control and assurance.
- Strong communication/collaboration ability with senior LT.
- Strong leadership, self-motivation, self-discipline, ability to organize own activities and team’s activities.
- Project management and people management skills.
- Knowledge of the legislation of the Russian Federation and the Eurasian Economic Union (EAEU), as well as processes in the field of circulation of medicines and in the field of GMP inspections.
- Pharmaceutical / Chemical / Microbiology education.
- Proficiency in English (advanced level).
Откликнуться на эту вакансию: Quality Systems and Compliance Director (GMP Director)
Предыдущая вакансия:
Вакансия № 21251155 на должность Инженер-проектировщик ОВИК от компании ООО Продвинутые решения в городе (населенном пункте) Москва