Специалист по качеству (Фарма)

Международная фармацевтическая компания открывает конкурс на вакансию: специалист по качеству.

Ключевое требование - уровень английского языка B2.

Опыт работы по вводу в гражданский оборот будет преимуществом.

Key responsibilities

• Maintain local Quality System Documentation: procedures, Working instructions and records
• Support in periodic Self-inspections/Internal audits according with the self-inspection plan and puts in place necessary corrective measures
• Deviation and CAPA management: collect and enter cases in CARA system
• Change Control management
• Support in product recalls in Russia
• Prepare quality metrics (KPIs) as per Corporate procedure
• Support in a proper GxP vendors and customers qualification, Quality and Security Agreements signing (when applicable)
• Participate in external audit and support with collection of information requested by internal and external auditors
• Develops Risk Assessment for cases defined in Quality System documents
• Work with complaints intake process in Russia
• Support in local ISO 9001:2015 certification cycle in Russia
• Perform other activities as required by Direct manager (local Head of Quality) and Corporate QA Head

Ensures implementation of following Quality Operations:

• Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
• Customers oversight: periodic customer License verification
• Product Quality status and batch release into civil circulation in Russia
• On time local QC testing completion, CoA review/ translation and local release, when applicable
• Handling quality events with team from impacted markets
• Sampling requested by HA (product, procedures, reference substances)

4. Quality Risk Management

• Support in preparation of Quality Risk Management for Russia

Условия:

- Официальное трудоустройство по ТК РФ;

- Социальный пакет: оплата питания, моб. связь, ДМС +1, страхование жизни);

- Привлекательная бонусная система;

- Возможность для карьерного и функционального развития внутри компании.