QA Manager Russia & CIS (Head of QA)

☑ 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.

☑ 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.

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

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