QA Manager

Вакансия № 18393727 от компании Brunel Russia на Электронной Службе Занятости Населения Москвы.

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☑ Основной блок:

Опыт работы: не требуется.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 18393727 добавлено в базу данных: Суббота, 8 марта 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Статистика предложения работы № 18393727:

Прочитано соискателями - 136 раз(а);
Отправлено откликов - 0 раз(а);

☑ Репутация компании "Brunel Russia":

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☑ Подробности о вакантном месте:

Our client - international pharmaceutical company (specialized in ophthalmological products), is looking for QA Manager to lead the Company EAEU quality operations as the local QA Lead of Russia and CIS for covering medicinal products, medical devices and nutritionals

Responsibilities:

Ensures the local quality management system and standard operating procedures are in place and in compliance with local regulations in RUSSIA/CIS countries covering (where relevant) e.g. importation check/local batch release, testing, complaint handling, recall, deviation management, change control, training, internal audits.
Actively collaborate with Russian and CIS leadership team members to raise QA matters and expertise to support business growth
Responsible for QA agreements with local Russian contractors and Santen affiliates and provide expertise for the relevant Quality Agreements for supporting the EAEU business
Audits, controls and coordinates with suppliers in Russia and CIS and ensuring appropriate storage and distribution of Santen’s products in accordance with Santen’s requirements
Coordinates and participates in inspections of the EAEU regulatory authorities at the Santen manufacturing/contract manufacturing sites
Ensures the local batch release in RUSSIA and support the local batch release in CIS countries
Acts as the local contact person for recalls in RUSSIA and responsible for periodic recall simulations in RUSSIA and support the recall process and periodic simulations in CIS countries
Act as the local contact person for product complaints in RUSSIA and support the complaint handling in CIS countries
Maintains current knowledge in the EAEU regulatory and legal requirements to ensure technical support in respect to all quality-related matters
Ensures the effective internal audit system in RUSSIA and CIS countries is in place
Participate in EMEA QA projects
Promote a culture of bottom – up open innovation in the country / cluster to strengthen Customer Centric operational activities.
Accountable to identify and grow the organizational and individual development among the team including hiring talents, on boarding, driving performance, coaching and feedback.
Act as deputy for local contact person for safety vigilance

Requirements:

Medical, pharmaceutical or chemistry education
Understanding of Russian local legislation and EAEU legislation
English upper-intermediate
A minimum of 5 year experience working in a pharmaceutical industry in the Quality Assurance
Strong knowledge of medicinal and medical device regulation (Russia, EAEU, CIS)
A minimum of 2 years Leadership experience
Advanced MS Office skills (Word, Excel, PowerPoint, Outlook, SharePoint)
Previous experience in international company

Company offers: