Діана

Competences
Communication:
I am a strong communicator, and I am confident in my ability to work collaboratively with a range of stakeholders in a variety of contexts.
Adapability
I have, during my whole life, been used to working with people from many different countries and I believe that I have the ability to fit into any kind of culture and environment. The reason is, that I have respect for other people and their believes.
Service minded:
I like to help other people and colleagues during my work.
I want to serve people and make them believe that I prioritize their needs for support before others.
Learning:
I am strong in learning and to search information through the internet and other literature sources.
Medical:
I have worked within the medical business and know the basic requirements within this area. I like to make a difference for the people’s quality of life. I am structured and I am very much aware about the requirements for preparation of documentation within the healthcare business.
IT:
Word, Excel, PowerPoint, The Bat, GMP, Java Script, CSS, HTML, React, SQL), IFS, 1-С
Personally

I will characterize myself as welcoming, accommodating, open minded, truthful, friendly, thankful and I have a good sense of humor, which I believe is very important!

Work experience
2019 - 2021

Logistic and quality manager, Medical сorporation Tetafafm
• The analysis, planning, and control over the realization of production in Ukraine
• The control over the quality of production according to the International Standards.
• The order of the goods and carrying out of negotiations with foreign countries.
• Translations of documents for customs and technical instruction for the equipment.
• Preparation of batch documents for customs clearance and the control over terms of custom registration of luggage that has arrived from Europe and Asia.
• Search of new carries, preparation of contracts, insurance of cargos.
• Choice of carriers and optimum transport
• Calculation of terms and costs of deliveries
• Planning and the coordination of term of delivery of a cargo from the countries of the Europe and Asia
• The control over shipment of the goods across Ukraine

2013 - 2016

Leading Specialist, Lviv Regional State Administration, Department for International Cooperation and Tourism
• Preparing and implementing visit programs of foreign delegations to Lviv Region according to the rules of State protocol;
• Preparing of information and analytical materials for the meetings of the governor with foreign delegations;
• Organizing of working visits and permanent consultative meetings with the leaders of regions of the foreign states;
• Representatives of diplomatic corps;
• Establishing and deepening contacts with the sister regions of foreign states and various international institutions;
• Dealing with official documents

2010 - 2012

Logistic manager, Аrterium» corporation
• Timely providing goods by the values of firm;
• Search of suppliers and adjusting of direct connections;
• Preparation of materials and leadthrough of tenders;
• Preparation of documents and control after arrival of commodity and by the lead through of payments;
• Iintroduction of information and work is in the system of 1C;IFS, GMP

2008 - 2009
Quality Manager, Corporation of Tyco Electronics
• Control of raw materials
• The control of production quality shipment of the goods
• Creating the IPCR, FlowChart, FMEA та Control Plan for new goods and translating it`s
• Carrying out of internal audits on quality

Education
2007
Ukrainian association of quality " Pryrost -Academia", in a direction " Management Systems of Quality and Internal Audit ( ISO 9000:2000), Certificate of Internal auditor of Quality, Kyiv

2004 - 2006
National University "Lvivska Politehnikc" specialty
„Economics and Business”, master of " Finance", Lviv.

2004 -2006
National University "Lvivska Politehnica" Institute of Telecommunication of Radioelectronics and Electronic Techniques, speciality " Physical and Biomedical Electronics", master of "Engineer" Lviv.

2000 - 2004

National University "Lvivska Politehnica" Institute of Telecommunication of Radioelectronics and Electronic Techniques, bachelor of " Electronics", Lviv.
2023
Medical Introduction Courses (Pharma4ever)
Basic GMP rules and authority expectations
The course gave a basic introduction to the Good Manufacturing Practice area with the pharmaceutical and medical device business. The content covers topics like device design, equipment design, behavior in pharmaceutical production environment and GMP related to handling of finish products.

Good Documentation Practice (GDP) & Good Test Practice (GTP)
The course gave a solid introduction to both the GDP and GTP area. The GDP part was focusing on how the documents should be written for fulfilling authority expectations within the medical business. The GTP was focusing on the different types of documents within the test area and which basic rules you must take into consideration when you have to perform the different tests.

Medical Device Legislation (EU and US)
The course gave a solid introduction to the European medical device legislation MDR 2017/745. The content of the course was focusing on the authorities’ expectations to the medical device manufactures technical documentation. Furthermore, the course gave a short introduction to US FDA medical device approval process.

Design Control – Medical Device
The course gave a solid introduction to the technical documentation required by the European medical device legislation (MDR 2017/745). The course was focusing on the key documents like Clinical Evaluation, Risk Management and biological evaluation.

Risk Management Process
The course gave a solid introduction to risk management process with basis in the ISO 14971:2019 standard covering the medical device area. Furthermore, the course also covers the general FMEA process for equipment within the pharmaceutical business.

Equipment Validation (IQ, OQ & PQ)
The course gave a solid introduction to equipment validation area going through the three different disciplines, Installation Qualification, Operation Qualification and Performance Qualification and the different validation documents.