Вакансия: QA manager

от компании (организации): ООО ЯДРАН в городе (населенном пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с оплатой труда: по договоренности

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Вакансия № 14653431 добавлена в базу данных сайта Электронный Центр Занятости Населения: Воскресенье, 1 июня 2025 года.
Дата обновления вакансии № 14653431 на сайте Электронного Центра Занятости Населения: Воскресенье, 29 июня 2025 года.

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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;
• Annual bonus from the fourth month of work;
• Mobile Compensation.

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