Контактная информация

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Опыт работы

Quality assurance engineer

с 04.2025 по наст. время (1 год)
Interchemie Werken “De Adelaar” Eesti, Інші країни (Хімічна промисловість, фармацевтика)

•Maintain and update Quality Management System (QMS) documentation: Quality Manual, SMF, SOPs, and WI.
•Participate in CAPA, Change Control, and Deviation/Event management processes; maintain relevant registers.
•Lead deviation and event investigations, identify root causes, and implement preventive and corrective actions.
•Implement a new CAPA system, manage CAPA reports, monitor execution, and verify CAPA effectiveness after action closure.
•Manage Change Control process to ensure timely evaluation, approval, and documentation of all changes impacting product quality and compliance.
•Take part in internal and external inspections (including GMP audits) and prepare supporting documentation.
•Contributed to the preparation and documentation of risk management reports related to product quality and GMP compliance.
•Implement a personnel training system for employees; develop training plans and training logs for staff across all departments.
•Organize and conduct personnel training on updated QMS documentation.

Training Engineer

с 01.2024 по 04.2025 (1 год 4 месяца)
Farmak, Київ (Хімічна промисловість, фармацевтика)

•Organized and monitored internal staff training programs using SAP Success Factors VLMS and offline formats, ensuring all personnel received up-to-date knowledge on quality standards and procedures.
•Developed, implemented, and maintained initial and periodic training programs for Quality Control Department personnel, tailored to role-specific responsibilities.
•Planned, organized, and controlled training on new and revised pharmaceutical quality system documents to ensure compliance with GMP requirements.
•Coordinated onboarding and adaptation training for newly hired employees at all stages, supporting their smooth integration into departmental processes.
•Participated in qualification commission meetings for personnel approval to conduct independent work.
•Developed and maintained up-to-date QMS documentation used by QC Department personnel.
•Created, updated, and evaluated the internal list of trainers, ensuring competence and continuous development of training staff.
•Developed and updated the internal “Passport” of the Quality Control Department.

Engineer

с 08.2022 по 01.2024 (1 год 6 месяцев)
Farmak, Київ (Хімічна промисловість, фармацевтика)

•Entered and verified static data for materials and products in LIMS LabWare for quality control workflows.
•Ensured compliance of electronic documentation with specifications, control methods, and regulatory requirements.
•Updated sampling standards and microbiological control frequencies for raw materials and finished products.
•Maintained accurate data within SAP ERP, including time norms and reagent standards.

Engineer

с 06.2017 по 08.2022 (5 лет 3 месяца)
Мікрохім, Рубіжне (Хімічна промисловість, фармацевтика)

•Developed and updated internal laboratory SOPs in compliance with Pharmacopoeia of Ukraine (PhU) and European Pharmacopoeia (Ph. Eur.).
•Prepared analytical reports and verified testing protocols.
•Performed quality control of raw materials, intermediates, and finished products using analytical instrumentation.
•Participated in equipment calibration, qualification, and requalification.
•Maintained laboratory documentation and ensured GMP compliance.

Образование

Dahl East Ukrainian National University

Chemical Technology and Engineering, Рубіжне
Высшее, с 2017 по 2019 (2 года)

Dahl East Ukrainian National University

Technology of Pharmaceuticals, Рубіжне
Высшее, с 2012 по 2017 (5 лет)

Дополнительное образование и сертификаты

«Organization and evaluation of the effectiveness of training for personnel of pharmaceutical manufacturers and distributors»

2025

Знания и навыки

• Відповідальність
• Контроль якості продукції
• Здатність до навчання
• Дисциплінованість
• MS Excel
• Адаптивність
• Ведення документації
• Чесність
• Неконфліктність

Знание языков

• Английский — выше среднего
• Украинский — свободно

Рекомендации

Кузьменко Ірина

Кузьменко Ірина

Head of QC Department,, Farmak

Дополнительная информация

Quality Assurance Specialist with experience in managing Quality Management Systems and training personnel in the pharmaceutical industry. Over 8 years in quality control and quality assurance roles, demonstrating skills in CAPA, deviation management, and effective documentation practices. Achievements include successfully updating QMS documentation and facilitating personnel training on crucial quality procedures.