Oleksandra Boiko
Regulatory Affairs Specialist at Delta Medical- Claim this Profile
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Bio
Experience
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Delta Medical
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Switzerland
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs Specialist
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Jan 2022 - Present
Managing the registration process of food supplements and cosmetic products in Ukraine, countries of CIS, Uzbekistan. Project support from the moment of product development to the moment of import. Labeling creation, packaging material development. Obtaining hygienic conclusions on cosmetic products and reports on dietary supplements. Communication with foreign partners/manufacturers. Managing the registration process of food supplements and cosmetic products in Ukraine, countries of CIS, Uzbekistan. Project support from the moment of product development to the moment of import. Labeling creation, packaging material development. Obtaining hygienic conclusions on cosmetic products and reports on dietary supplements. Communication with foreign partners/manufacturers.
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CRATIA LTD.
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United Kingdom
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Consumer Services
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1 - 100 Employee
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Regulatory Specialist
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Dec 2020 - Jan 2022
Obtaining reports on compliance with the requirements of the Sanitary Legislation of Ukraine and European Regulations for dietary supplements and baby food (full cycle); Registration of cosmetic products (full cycle); Registration of disinfectants (full cycle); Obtaining conclusions of sanitary-epidemiological examination on medical devices; Preparation of labeling texts, in accordance with the current requirements of the law; Monitoring changes in legislation; Correspondence with foreign customers; Correspondence and close cooperation with state bodies, expert organizations and authorities. Show less
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Amrita
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Киев, Украина
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Quality Specialist
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Nov 2018 - Dec 2020
Ensuring availability of quality certificates and permits for raw materials and finished products; Control of tests of raw materials and finished products; Development of Technical conditions for products; Implementation of the HACCP system; Working with regulatory documentation (Standards, Technical Regulations); Interaction with state authorities. Ensuring availability of quality certificates and permits for raw materials and finished products; Control of tests of raw materials and finished products; Development of Technical conditions for products; Implementation of the HACCP system; Working with regulatory documentation (Standards, Technical Regulations); Interaction with state authorities.
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FACTORIA-AGRO.LTD
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Ukraine
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Food and Beverage Manufacturing
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1 - 100 Employee
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Quality Engineer
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Apr 2018 - Nov 2018
Development of quality management system documentation; Development and implementation of measures to create production conditions in accordance with the requirements of international standards in the field of food safety and quality; Control over compliance with sanitary and hygienic requirements in industrial and household premises; Development of instructions and training of employees; Development and implementation of an integrated quality system to meet the requirements of ISO 9001, ISO 22000, FSSC22000 standards; Participation in internal and external audits; Preparation and conduct of Halal, Kosher audit; Control of laboratory work. Show less
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Vertograd Juice
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Киев, Украина
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Head of Quality
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Aug 2017 - Mar 2018
Organization and control of laboratory work; Management of the product quality control process; Planning and conducting audits; Development and implementation of quality standards (ISO 22000, BRC, FSC, HASP, etc.) in production; Management of the product certification process; Preparation of reporting on quality issues; Interaction with state authorities. Organization and control of laboratory work; Management of the product quality control process; Planning and conducting audits; Development and implementation of quality standards (ISO 22000, BRC, FSC, HASP, etc.) in production; Management of the product certification process; Preparation of reporting on quality issues; Interaction with state authorities.
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KSM Protec
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Киев, Украина
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Technological engineer
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Jun 2016 - Aug 2017
Development of recipes for the production of oils and plastic lubricants, automotive chemistry, editing and changing recipes according to the available raw materials, writing technological maps, monitoring compliance with the norms and parameters of the technological process, checking the conformity of the results of TU and GOST analyzes and, if necessary, making corrections, writing off raw materials, production of finished products according to 1C, control over packaging of products. Quality control of finished products and incoming raw materials for compliance with the requirements of standards and regulatory documents, organization of laboratory work, coordination of the work of laboratory assistants, interaction with all departments of the production workshop, keeping records and laboratory documentation, finding and ordering necessary materials and equipment. Show less
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LLC Cherkasky Auto Chemical Plant
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Черкассы, Черкасская область, Украина
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Research Engineer
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May 2013 - May 2016
Research of samples of raw materials, development of recipes for the production of auto chemicals, testing of samples of competitors' products. Research of samples of raw materials, development of recipes for the production of auto chemicals, testing of samples of competitors' products.
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Econia
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Ukraine
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Food and Beverage Services
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Laboratory assistant of microbiological research
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Jun 2012 - May 2013
Conducting microbiological tests (preparation of materials, sampling, bacteriological inoculation, collection of results). Document circulation (maintenance of lists of current documentation, tracking of validity periods and updating of documentation, archiving of documentation). Conducting microbiological tests (preparation of materials, sampling, bacteriological inoculation, collection of results). Document circulation (maintenance of lists of current documentation, tracking of validity periods and updating of documentation, archiving of documentation).
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Education
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ЧДТУ