Вакансия № 4102837 на Электронной Службе Занятости Населения от компании Бакстер на должность Руководитель по обеспечению качества, QA Head, Head of Quality Assurance в населенном пункте Москва

☑ Основы вакансии:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Место работы (точный адрес): Россия, Москва, Войковская, Ленинградское шоссе, 16ас1.

Это объявление № 4102837 добавлено в базу данных: Понедельник, 8 апреля 2024 года.

Дата его обновления на этом интернет-ресурсе: Среда, 24 апреля 2024 года.

Прочитано соискателями - 151 раз(а);
Отправлено откликов - 0 раз(а);

Lead efficiently the Regional Team (Russia & CIS) reporting in to this position.
Assure CQA processes are in place in the Russia & CIS region:-
- Implementation, monitoring and maintenance of Baxter Quality Management System
- Post-Market Surveillance
  - Lead Product Surveillance activity for Drugs and Medical Devices
  - Complaint Coordinator activity
  - Field Action implementation and execution
- Sales Authorisation, Hold, NCR, CAPA, Audit, Quality Review, Change Control
- Supplier approval and maintenance
- Distributor and 3PL approval and maintenance
- Validations
- Training, Regulations
Main contact person with Competent Authorities
Enterprise Resource Planning expert user (JD Edwards), release of products in Russia & CIS Region
- Ensure back up persons for critical processes in the Russia & CIS Region are appropriately trained and back up are always available.
To ensure that processes and procedure related to mentioned activities are compliant to local Regulations, to the Global Quality Manual and to the ISO 9001 and 13485 requirements.
To ensure appropriate contacts with country Regulatory Affairs, Vigilance, TS, W&D and Business Units (including manufacturing) are maintained.
Ensure appropriate contact with Russia & CIS General Manager and be the first contact for quality related issues and project support
Budgetary controls

The function requires a degree in Scientific or Technical Disciplines (preferable Pharmaceutical/Biotechnology/Chemical degree)
Solid experience in Quality Assurance and GxP - preference for Good Manufacturing Practice (production/quality control/post market surveillance) but can be within Good Distribution Practice (warehouse & distribution, post market surveillance)
In-depth Regulatory knowledge for Russia and CIS (current and future) and advanced skill set to host Competent Authorities/MoH during inspections or respond to regulatory requests
Desirable - Qualified Person – not currently obligatory requirement, but new regulation is coming in 2020
Additional knowledge or skills gained through a combination of academic study, job experience e.g:-
Ability to manage direct reports
Excellent interpersonal and communication skills
Ability to liaise with the different functions involved, Regulatory Affairs, Vigilance, W&D and Business Units (including manufacturing)
Russian, with very good spoken and written English

Обратите внимание на веб-сайт компании - http://www.baxter.com.ru/ - с подробной информацией об организации, в том числе контактными телефонами.

Логотип (эмблема, торговая марка, бренд) компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; Промышленное оборудование, техника, станки и комплектующие; .