Provide strategic development to the Distribution department on implementation and adoption of continuous improvement approach.

• Maintaining of quality management system at 3PL and Distribution at a proper level; • Provide strategic development to the Distribution department on implementation and adoption of continuous improvement approach. • Proactively monitor Russian and EEU legislation to ensure timely changes in distribution activities. Ensure Wh operates in line with GDP standards • Be key contact person for QA and SC stakeholders for CAPA and further distribution development to ensure connection between daily operations and strategic initiatives; • KPI: control, timely review and tracking; • Develops a positive and pro-active customer service attitude for both Distribution and 3PL team; • Provide leadership to ensure that 3PL team are qualified and competent, properly coached. • Budget design & optimization: preparation, review, control of expenditure. Continuous improvement initiatives related to cost optimization. • Interface with Supply Chain organizations (internal and 3PL organizations) for planning and product release to the market; • Compliance & Risk management. Lead Internal controls (SOXs) & audit activities to ensure processes compliance; • Regularly update internal procedures (is required);

- Daily KPI of quality items in the business (Tracking of PRs raised iComply training, Client based PRs, Internal PRs, GDP, GMP, Training, Logistics, complaints). - Management of the Quality Management System - Document control and quality management. - Ensuring iComply training of all employees in facility is up to date TrackWise operation and iComply administration. - Compiling and presenting monthly Quality Management Review meetings of all quality metrics in the facility. - Internal assessments to ensure compliance to the SOPs and Quality Policies. - Ensure an effective quality management system with accordance to the relevant standards. - Responsible for compliance for FCS to establish quality procedures GxP standards - Responsible for the management of non-conformances, deviations, complaints and investigations. - Leads liaison with clients and key suppliers on audits and quality related matters and to provide guidance and advice to clients, suppliers and internal associates on quality matters. - Identification, validation and qualification of facilities/equipment, inclusive of the review and approvals of validation related reports. Driving continuous improvement initiatives through the information generated by compliance monitoring and cGMP requirements. Develop, implement and maintain of a quality plan. - Manage external supplier audits. - Identify quality related training and provide training to employees - Managing change control process. This includes but is not limited to: ensuring risk assessment and pre change criteria are met, ensuring validation activities are performed to cGMP standards, providing guidance Management and guidance of equipment and process validation. - Approval of DQ, IQ, OQ, PQ and analysis of validation results.Assessment of post change effectiveness. - Investigating and supervising investigations into non-compliance issues, deviations, complaints, and other adverse events. Forming CAPA plans, ensuring CAPAs are appropriate, leading CAPA plans through to execution and ensuring CAPA effectiveness. - Quality review and approval of EPOs, in-process Quality checks, review and approval of EBRs, Release of materials, - etc.

- Control of production documentation; - Investigation of deviations/observations; - Change control; - collection and analysis of reclamations; - self-inspection.

Coordination of all departments of the factory, elaboration of expenses norms, obtain effective reasons and output of poor quality products, development actions for high quality products and more efficiency of equipment. Development of production program and schedule diagrams of product release, control of production stages. Development and agreement of technological regulations (reglaments), etc.

Development, introduction and control of quality system documentation (SOPs), self-inspection, internal and external quality audits, suppliers audits, working with ISO 9001 standard, negotiations with foreign clients, collaboration in Site Master File preparation.

Control of all environment and health protection norms at the factory, study of work conditions, establishment of privileges and compensations by work conditions, works of utilization of medical waste, household waste. Investigation of accidents, trainings, elaboration of ecological documentation, etc.

Институт дополнительного профессионального образования, Фармация

Общеэкономический/финансы и кредит, Диплом

Технологический/охрана окружающей среды, Диплом

Кафедра иностранных языков/переводчик, Диплом

Российский университет дружбы народов (РУДН) , Сертификат