Менеджер по контролю качества/Quality Control Manager

Legislation related to laboratory testing:

• documents monitoring
• presentation updating

Reference standards and reagents ordering and support of shipment:

• communication with Global reference standard group
• coordination with Global Laboratory team
• coordination with Global Trade Compliance
• communication with local partners
• negotiation with external laboratories (Pharmoborona, Roszdravnadzor,etc.)

Paper-based testing organization:

• communication with local partner and support of Risk Assessment
• coordination with Global laboratory team/testing laboratory
• creating of agreements/contracts (if applicable)

Virtual testing:

• coordination between Global Laboratory team and local laboratory
• slides updating (slides for laboratory, communications with laboratory)

Test method transfer:

• coordination of the process between given and receiving laboratories
• cross-functional coordination with RA department
• to prepare all necessary activities for the TMT

Support of localization process:

• coordination of the reference standard and reagents ordering
• negotiation and coordination of alternative testing (remote, paper-based, etc)

Support of GMP inspections (30 %):

• application submissions
• inspection organization (site preparation, traveling, evaluation of interpreters)
• CAPA implementation process