от компании (организации): ООО ЯДРАН в городе (населённом пункте): Москва, Россия
в отрасли экономики "Закупки" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 13843173 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 6 октября 2024 года.
Дата обновления вакансии № 13843173 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 13 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 13843173 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: QA manager
Responsibilities:
- Maintains, development and support of the local QA system in line with global / local procedures; adaptation of SOP HQ to local SOP and their implementation in accordance with local regulatory requirements;
- Maintains and implementation of the local QA Standard Operating Procedures and the local QA- Guidliance;
- Description and implementation of the risk management plan, deviations management plan, CAPAs and business continuation plan processes with respect to compliance with GDP& GSP- rules;
- Description of the warehouse’s processes of acceptance, storage and transportation of medicinal products from the time of customs control to shipment;
- Collect of the quality compliance reports, collaboration with manufacturing sites on compliance reports follow up;
- Provide on a permanent basis of the monitoring of the detection of product inconsistencies. Providing communication with patients on product quality issues;
- Organization of product quality control, selective control; collaboration with laboratories and certification centers, control of the supply chain from production to distributors;
- Disposal of drugs in accordance with the procedures;
- Support of audits of warehouse operator, logistics transportation companies and distributors with respect to compliance with GSP& GDP- rules;
- Management of external audits, handling complaints, drug reviews. Ensuring daily monitoring of the detection of potential cases of falsification of drugs. Ensure communication with applicants on relevant MFG sites on product quality and complaints received;
- Storage of QA documents;
- Timely implementation of all the necessary training on the quality of the documents, processes, procedures in accordance with the requirements in a timely manner;
- Internal and external audit, control and coordination of third-party activities, storage and/or distribution carried out in accordance with the standards;
- Communication with HQ;
- Coordination of the Data Matrix project (serialization);
- Internal collaboration with Logistic, Marketing, Regulatory and Legal departments
Requirement:
- Higher education (technical, pharmaceutical, in the field of quality management);
- Knowledge of the legislation in the field of the use of medical medicines and medicines in the Russian Federation;
- Experience in the field of quality assurance in pharmacy, knowledge of the requirements of ISO, GMP (GxP);
- Experience in the implementation and compliance with standards and technical specifications for product quality;
- Skills written procedures and interactions with regulatory systems;
- From 3-6 years of experience;
- English - Upper intermediate.
Conditions:
- Work schedule 5/2, Mon-Fri, 09.00-18.00
- VMA program - from the fourth month of operation (outpatient care, hospitalization, dentistry, travel insurance + accident insurance);
- Quarterly bonus from the fourth month of work;
- Mobile Compensation;
- Travel Compensation.
Откликнуться на эту вакансию: QA manager
Предыдущая вакансия:
Вакансия № 13843158 на должность Личный ассистент / бизнес ассистент от компании ООО Мобильные Медицинские Технологии в городе (населенном пункте) Москва