Conduction of external audits to:

- Manufacturers of API's; in bulk products; contract production;

- Manufacturers of primary and secondary packaging; clothes for clean areas;

- distributors; API suppliers;

- evaluation of excipients;

- self inspection to other departments;

- audit report purchase from a third party;

- support in clothing CAPA to a clients.

-ensuring of implementation and functioning of the quality management system and it’s compliance with Ukrainian legislation;

-management of CAPA; Deviation; Compliance; Risk management, recall (Mоck recall);

- cooperation with PV and other releated departments in in related activities;

-product incoming control assurance;

-documents submission for obtaining Conclusion;

-actions to release batch on the market;

- management and control processes on a Warehouse;

-communication with manufacturers, global office;

-self-inspections, audits;

-quality assurance processes support for other countries markets;

- creation and update of SOP’s, Manuals, Quality Agreements, Importer Dossier.

-interaction with State Service of Ukraine on Medicines and Drug Control in obtaining Conclusion for batch release;

-performance inspection on Technical Agreements actualization;

-support on creation and updates of quality documentation;

-control submission of changes product related to State Service of Ukraine on Medicines and Drug Control;

-interaction with local and global company departments in solving issues related to the performance of duties.

• performance administration of change management - direct responsibility on a drive and coordinate all brand related regulatory relevant change requests and master data maintenance;
• timely implementation of all on-going life-cycle activities;
• liaise with country managers regulatory affairs departments, business process owners and customers to facilitate working out and implementation of change request;
• participate in issuing and reviewing registration dossier.

• authorization or rejection (defect) of medicine products ( medicines and medical devices);
• coordination of subcontracting work that may affect GDP;
• interaction with regulatory authorities;
• hosting of company global internal audit;
• hosting license audit from State Service of Ukraine on Medicines and Drug Control;
• conduction of client validation;
• audits conduction (distributor, service providers);
• ensure proper validation, qualification of equipment and systems (computer system);
• performance of Importer Dossier;
• performance of recall process;
• take part in scheduled EAME QA meetings.
• conformity of GXP practices, ISO's, ICH Q6 and Q9 related to performance official duties;
• conformity of Ukrainian legislation, related for performance official duties;
• ensuring regular self-inspection;
• inspections of medicinal products imported into Ukraine territory that are accompanied by a necessary documentation;
• incoming control of medical products and documentation;
• Risk-Management;
• conduction of scheduled self-inspections;
• changes management;
• conduction of quality reviews;
• employee training conductions;
• creation of SOP's, Instructions and support and updates of quality documentation;
• performance of Updates of Technical Agreements;
• keeping a register of medicinal products that have been received by the entity.
• ensuring implementation and functioning of the quality management system;

• formation of PSUR, ACO;
• processing messages;
• creation an integrated assessment of risk / benefit ratio;
• monitoring of safety information on the medicines;
• database support and up to date;
• carrying out training about pharmacovigilance for other departments;
• preparation of responses to regulatory authorities;
• formation of changes in the IMU;
• formation documents for re-registration procedures and submission to regulatory authorities;
• interaction with Regulatory and Quality departments in related actions;
• monitoring stops of series and implement bans of drugs by regulatory authorities;
• formation of SOP's for competencies and business processes;
• monitoring changes in legislation for pharmacovigilance.