Quality Assurance specialist (GMP)

☑ Основной блок:

Опыт работы: 1–3 года.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 735376 добавлено в базу данных: Понедельник, 17 марта 2025 года.

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

☑ Репутация компании "VALEANT":

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☑ Подробности о вакантном месте:

RESPONSIBILITIES

Quality Management System (QMS) Building

• Writing/updating SOPs and operational instruction;
• Track the SOPs list/QMS Plan – control of timely implementation and updating;
• Carrying out/control/documentation actions for CAPA, Deviations, Change control (etc.) processes
• Documentation management

Quality Compliance

• Site Quality Plan implementation;
• Responsible for trainings:

1. For newcomers;
2. Annual trainings for all staff (including development of trainings);

• Assessment of PQR’s;

Quality Assurance Agreements (new/updates)

• Database update and maintenance.

Quality audits/checks

• Internal audits.
• Support activities if required (administrative/organizational).

Product Quality issues

• Preparation of official letters;
• Routine daily checks of HA database (check the presence of official prescriptions);
• Documentation (registration in the file, printing, archiving).
• Conclusion of contracts with laboratories/service suppliers (for purchasing chemical reagents, reference standards);
• Organization of independent expertizes in laboratories upon VALEANT initiative

GMP-inspections /(Inspections of MD Manufacturing Sites in future)

• Development of templates and list of documents to be provided on the basis of local legislation requirements;
• Requesting the documents;
• Checking the accuracy and completeness of provided documents;
• Communication with MS/EMQA;
• Control the statuses on each stage of process (from the requesting docs till the receiving GMP-certificate);
• Collaboration with inspectors and experts of Ministry of Industry and Trade;
• Control of application statuses in Ministry of Industry and Trade;
• Coordinate the concluding of contracts and paying for state service of inspection.
• Collaboration with compliance in terms of paying for inspection;
• Tracking and coordination of inspection schedules;
• Supporting all the activities in terms of project.
• Participation in inspections;
• Control of CAPA preparation and closure.

Local declaration process

• Support updates/changes in CoAs if required.

CIS

• Support for quality queries;
• Ordering reference standards upon request;

QA projects

• Cross functional collaboration in projects with QA involvement;
• Consulting on quality GMP topics;

JOB REQUIREMENTS

• Work experience: 1-2 years in pharmaceutical company in Quality Assurance field
• English language: intermediate / upper-intermediate
• Education: higher education (chemistry, biology, pharmacy specialization)
• Additional: stress-resistance, multitasking skills, PC advanced user, knowledge of local and international standards, the possibility for business trips (warehouses in Moscow district)
• Strong knowledge of local legislation, international standards and practices for manufacturing and distribution of medicinal products and medicinal devices.

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