Старший менеджер по обеспечению качества (фармацевтика)
Киев • 29 лет
Senior quality assurance engineer в Farmak6 лет 1 месяц
Validation engineer в Farmak8 месяцев
Validation engineer в Biofarma9 месяцев
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Working with leading european consultants, supporting international audits from Poland and Croatia in risk management field.
Work in team that successfully achieved European GMP certificates for our company.
сент. 2014 - н/вFarmak
янв. 2014 - сент. 2014Farmak
Validation documentation development, such as:
марта 2013 - дек. 2013Biofarma
Equipment and utilities validation.
Development of validation documentation, such as:
Develop requirements for FAT, SAT.
Performing factory acceptance tests for filling and capping equipment, sterilization tunnels, moist heat sterilization equipment, vials, ampoules and bottles washing machines, syringes filling machines, labeling and package equipment.
Working in Italy as a leader of FAT-group of plastic bottles filling and labeling line (Bologna, Marchesini Group), and a member of FAT-groups in Siena (Neri), Florenzia (Co.Ri.MA).
Год окончания 2013Pharmaceutical biotechnology, Specialist
Год окончания 2015Certificate "Deviation management and change control, including ICH Q10 requirements"
Год окончания 2015Certificate "Quality Management systems according to ISO 9001:2009, ISO 22000:2005, ISO 13485:2005 and risk management according to ISO 14971:2009" from 08-10 June 2015
Год окончания 2015Certificate "Methodology of identification and analysis hazard factors, planning corrective and preventive actions, according to HACCP with compliance of ISO 22000:2007
Год окончания 2015Certificate "Quality Risk management" - Gratitude for presenting of practical approaches into using of risk instruments FMEA and RRF in pharmaceuticals industry on international conference
Год окончания 2015Certificate "Internal audit of food products safety management system in accordance to ISO 19011:2012:
Computer Skills and Additional information:
Free user: SAP, Infotehna, AutoCAD.
Preferred branches: quality management, validation (equipment and utilities), technology support. Willing to consider other proposals.
Objective: Obtain position in quality management or validation (equipment and utilities), or technology support department in international pharmaceutical company.