- Evaluating and analyzing trend quality indicators, data and performance metrics (KPI)

- Supporting internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.

- Coordinating change control processes to ensure changes do not introduce adverse impact to operation.

- Providing guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

- Quality Agreements handling.

- Lead Auditor role during self-inspections, supplier and internal audits. - - Covering of Incident Management Process.

- Recalls and Mock Recall Handling.

- Coordinating and supporting activities related to quality events (quality defects, security events, recalls etc) in the affiliate.

- Quality support of 11 countries (CIS countries and Ukraine).

- Complaints, Deviations, CAPA, Change Control processes management

- Developing, approving, distributing and trainings of local standard operating procedures

- Administration of Veeva Vault, LEADs, EQMS, Track Wise and SAP Success Factors systems

- Self-inspection process management

- Conducting internal staff training (including induction quality training)

- Development of operational and regulatory documentation at the company (SOP, Standards)

- Development of the process of conducting non-compliance investigations at the company, including corrective and preventive actions

- Manage outsourcing activities including warehouse (logistic provider).

- Risk identification and assessment.

- Qualification of suppliers (questionnaires, due diligence, risk calculation etc)

- Qualification of customers.

Conducting internal staff training.Development of operational and regulatory documentation at the company (SOP, Standards, Polices);Development of the process of conducting non-compliance investigations at the company, including corrective and preventive actions;Implementation of the process of change management, deviations and outsourcing activities;Risk identification and assessment;Cooperation with contractors;Drawing up and updating Technical Agreements with quality;Preparation for certification of the enterprise in accordance with the requirements of good practices (GDP / GSP);

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- Preparation for certification of the company for compliance with the requirements of ISO 9001: 2015 and the requirements of good practices (GDP and GSP);

- Development of operational and regulated documentation at the enterprise (including CPM and KP);

- Organizing and conducting investigations of deviations and discrepancies, corrective and preventive actions;

- Administration of documents related to quality assurance at the enterprise in electronic and paper form;

- Analysis of incidents and identification of measures to prevent the recurrence of similar situations in the future;

- Identification and assessment of risks at the enterprise;

- Qualification of warehouses, refrigeration equipment, vehicles equipped with a refrigerator and validation of computerized systems;

- Selection of equipment, creation and filling of tender tables and procurement (both in direct relation to quality assurance at the enterprise and not directly);

- Development of presentations for training of personnel at the enterprise (requirements of good practices, risk analysis, quality assurance in general).

- Development of regulatory and registration documentation of the quality system;

- Documentation of work performed on the processes of the quality system;

- Participation in the preparation of the necessary set of documents for licensing of enterprises and partner companies in accordance with the requirements of regulatory authorities;

- Participation in the organization, conduct and support of inspections of the company (GDP, GSP, ISO) carried out by regulatory authorities;

- Execution of works on investigation of deviations, discrepancies, complaints and other incidents (CAPA including);

- Participation in the organization of support of the quality system of the enterprise in full compliance with effective regulatory requirements;

- Validation / qualification works at the enterprise: warehouses (9000m2), refrigeration chambers (2000m2), refrigeration units and thermoboxes;

- Development, updating, implementation, training, dissemination of standard operating procedures;

- Organization of the process of metrological verification of measuring instruments at the enterprise;

- Verification of quality certificates in accordance with the requirements of Resolution 902 of 14.09.2005 (replacement of an employee of the OOC (pharmacist) during absence).

- Qualification of clean rooms, engineering systems and equipment;

- Development of validation and operational documentation in accordance with GMP requirements;

- Acceptance and participation in setting up equipment, launching clean rooms and engineering systems;

- Qualification of warehouses, refrigeration equipment, thermostats, vehicles;

- Participation in the qualification of reactors, autoclaves and sterilization tunnels;

- Qualification of packaging equipment, visual inspection.SOP update;

- Development of premises diagrams (Visio).

- Conducting the technological process of bottling drugs (Infusions / injections);

- Completion of regulatory documentation in accordance with the requirements of good manufacturing practice.

- Repair of equipment.Performing equipment reconfiguration.