Контактна інформація

Шукач вказав телефон та ел. пошту.

Отримати контакти цього кандидата можна на сторінці https://www.work.ua/resumes/6221032

Досвід роботи

Quality manager/ Responsible Person

з 07.2021 по 04.2023 (1 рік 9 місяців)
Takeda Ukraine, Київ (Медицина, охорона здоров'я, аптеки)

-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.

Quality assurance specialist

з 11.2020 по 07.2021 (8 місяців)
Sanofi Ukraine, Київ (Медицина, охорона здоров'я, аптеки)

-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.

Change Control manager

з 02.2020 по 06.2020 (4 місяці)
Ассіno, Київ (Медицина, охорона здоров'я, аптеки)

-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.

Quality manager/ Responsible Person

з 06.2017 по 02.2020 (2 роки 8 місяців)
Allergan Ukraine LLC, Київ (Фармацевтична)

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.

Pharmacovigilance specialist

з 06.2015 по 06.2017 (2 роки)
JSP "Halychpharm" Arterium, Львів (Медицина, охорона здоров'я, аптеки)

-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.

Освіта

Львівський Національний медичний університет ім. Д. Галицького

Фармакологія, Львів
Вища, з 2007 по 2014 (6 років 5 місяців)

Дрогобицький Державний педагогічний університет ім. І. Франка

Анлійська філологія та література, Дрогобич
Вища, з 2007 по 2012 (4 роки 9 місяців)

Знання і навички

Знання мов

• Англійська — просунутий
• Українська — вільно
• Російська — вільно