Senior Quality Assurance Operation Specialist

Вакансия № 286481 от компании АНКОР Медицина и фармация на Электронной Службе Занятости Населения Москвы.

☑ Основной блок:

Опыт работы: более 6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

Это объявление № 286481 добавлено в базу данных: Понедельник, 17 февраля 2025 года.

Дата его обновления на этом интернет-ресурсе: Вторник, 18 марта 2025 года.

Прочитано соискателями - 241 раз(а);
Отправлено откликов - 0 раз(а);

International pharmaceutical company is searching for Senior Quality Assurance Operation Specialist (Qualified Person) (in Saint-Petersburg)

Responsibilities:

Qualified Person function (current or in near future): accountability for commercial manufacture approval, verification of a batch dossier in accordance with internal and external requirements;
Assure that all validation and qualification activities are executed in accordance with legal, GxP & corporate requirements / standards;
Active participation and substantial help in solving quality problems and prevent their occurrence in the production, qualification and validation area;
Managing change control in the production and engineering area;
Participation in internal and external audits / inspections;
Review and approval of qualification and validation documentation concerning the manufacturing and packaging process of medicinal products to assure compliance with current marketing authorization, GxP and legal requirements;
Participation in the preparation of the required risk assessment;
Effective cooperation and substantial support to other departments related with activities of QA Operations Department Support of QAO Manager in projects (leading role);
Active participation in product transfer (signal contact for transferred products from QAO side).

Regirements:

Higher pharmaceutical / chemical education;
5 + year experience in Quality Assurance, Production, Technology, Validation department (only pharmaceutical experience);
Russian & English intermediate (speaking / writing);
Good PC user, familiar with all Microsoft office suite;
System thinking, good communication skills, excellent organization skills, multi-tasking and flexibility, active position, ability to take responsibility, independent.