от компании (организации): ООО Октафарма-Фармимэкс в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Фармацевтическая промышленность"
с заработной платой: по договоренности
Вакансия № 9004579 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 4 сентября 2024 года.
Дата обновления вакансии № 9004579 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 № 9004579 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 Control Manager
As an international family business in the plasma industry, we are proud of this: our products can save lives. We have strong European roots and are growing continuously. Therefore, we are looking for a Quality Control Manager, who will be responsible for all quality control activities of the Company in Russia including the development, design, implementation and startup of Quality Control laboratories required for the Fractionation facility.
Please submit your CV in English with the indication of the salary level.
The responsibilities of Quality Control Manager include but are not limited to the following blocks:
• Participate in the development and design of laboratories for the manufacturing facility:
- laboratory for incoming goods inspection
- microbiological laboratory,
- analytical laboratory.
• Ensure compliance with RU&EU regulation requirements.
• Ensure standardization of lab equipment, instrumentation, and assay methodology to internal requirements.
• Coordinate purchasing and supply of lab equipment, chemicals, consumables, furniture for the labs:
- define requirements;
- participate in supplier qualification and approval processes;
- ensure proper quality and timely supply of all purchased items;
- setup and manage contracts with external labs and service providers.
• Development/transfer of documentation required for set up and operation of QC labs on Fractionation facility, in compliance with internal standards, RU & EU regulation requirements.
• Preparation of transfer of methods, instruments, etc. for the implementation in the new facility according to the project plan:
- equipment qualification, transfer of test methods, and start-up of the laboratories in the new facility in compliance with EU and Russian regulations;
- accreditation and licensing of the laboratories according to Russian regulations.
• Organize the work of laboratories in accordance with the requirements for laboratories of pharmaceutical companies and internal policies and procedures. Ensure the development and improvement of the quality control system:
- perform quality control during qualification / validation activities, and routine manufacturing;
- interact with the State Authorities in terms of appointed responsibilities.
What we expect?
- Completed University degree in in Biotechnology, Chemistry, Quality, or Pharmacy;
- At least 5 years of working experience in similar position in a pharmaceutical company;
- Successfully completed education in Pharmaceutical Quality Management, sound knowledge of GMP/GLP and related guidelines, education/training in Project Management;
- Experienced in Quality control acumen, QC equipment qualification, Method validation / transfer, knowledge of Russian regulations and cGMP;
- Advanced user of Microsoft office programs;
- Excellent communication skills both in Russian and English;
- Readiness to travel to European facilities for project knowledge, training, and implementation, up to 30% of working time.
What we offer?
- Reliable employer with generous social benefits.
- Medical and life insurance;
- Mobile telephone compensation, daily meal allowance.
- International environment, friendly and highly-motivated team;
- Interesting and challenging tasks;
- Career advancement possibilities;
- 100% compliance with Russian legislation.
Do you want to become a member of our team? We look forward to receive your application in English!
Откликнуться на эту вакансию: Quality Control Manager
Предыдущая вакансия:
Вакансия № 9004575 на должность Микробиолог лаборатории микробиологического и фармацевтического контроля от компании ООО ФАРМАПАРК в городе (населенном пункте) Москва