QA Manager Russia & CIS (Head of QA)
Вакансия № 1664835 от компании VALEANT на Электронной Службе Занятости Населения Москвы.
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☑ Основной блок:
Опыт работы: 3–6 лет.
Тип занятости: полная занятость.
График работы: полный день.
Зарплата: по результату собеседования.
Примерное место работы: Россия, Москва.
☑ Актуальность объявления:
Это объявление № 1664835 добавлено в базу данных: Среда, 12 февраля 2025 года.
Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.
☑ Статистика предложения работы № 1664835:
Прочитано соискателями - 209 раз(а);
Отправлено откликов - 1 раз(а);
☑ Репутация компании "VALEANT":
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☑ Подробности о вакантном месте:
Responsibilities:
- Overall responsibility for development and implementation of the Quality Management System through the organization, developing ;
- Maintain and lead QMS processes: complaints, deviations, CAPA, change control, risk management, recall, and other;
- Provide expertize on quality and compliance, provide input and support for the local Quality Strategies, including interaction with Global team on this and continuous improvement.
- Leading QA issues at local and CIS level, collaboration with global quality departments, decision maker for the established area of responsibility;
- Lead investigator at local level for all quality related issues;
- Collaboration and establishment of effective communication with 3pl providers;
- Development of GDP activities through the affiliate activities;
- Follow and implement all quality compliance requirements, participate in Critical Action Committees;
- Reporting to HA, follow the prescriptions of authorities and development of action plans upon request.
- Communication and collaboration with quality control centers regarding expertizes and state quality control initiatives;
- Maintenance, updating and concluding QAA with vendors (GxP) – manufacturing sites, intra-company agreements, 3pl providers, transport companies, etc.;
- Management of outsourced activities;
- Audit of GxP suppliers in Russia and CIS;
- Support of logistic functions in terms of GxP processes and local regulations;
- Participation in localization activities;
- Support QMS development and GDP compliance of CIS affiliates and warehouses;
- RU GMP-inspections process owner (end-to-end);
- Support local declaration activities;
- Routine tasks in WMS;
- Reporting at local and global levels (QPI, performance plans, implementation of Site Quality Plans);
- Budget owner, rational planning of activities.
- Management of 2 subordinates,
Job requirements:
Education and Experiences Criteria
- Bachelor of Science Degree in Engineering , Pharmaceutical, chemical technological education or equivalent
- Fluently in Russian and English
- 5 years’ experience working in the Quality Assurance field, as well as, experience working with international standards and practices (GxP processes)
- Deep expertise and knowledge of pharmaceutical local regulations in Russia regarding circulation of medical products and MD
- People management background
- Proven experience in development and implementation of QMS
- Proven communication, leadership and technical skills. Understanding of GMP, GDP, and ISO requirements and the mechanisms to influence, as well as, successful interactions with regulatory agencies.
- Knowledge of management of Quality operations and processes.
Personality criteria
- Project management, technical writing ability and computer skills are required.
- Strong analytical and problem solving skills especially in non-conformance investigations. Ability to assertively interact with people at all levels of the organization. Ability to manage multiple priorities.
- Proven people management skills, team builder, strong stakeholder management skills and motivator.
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