Больше информации по резюме будет доступно после регистрации
ЗарегистрироватьсяБыла вчера в 17:56
Женщина, 44 года, родилась 29 ноября 1981
Москва, м. Саларьево, не готова к переезду, готова к редким командировкам
Quality assurance specialist (специалист по обеспечению качества)
Специализации:
- Инженер по качеству
Тип занятости: полная занятость
Опыт работы 22 года 10 месяцев
Июнь 2016 — по настоящее время
9 лет 11 месяцев
«GlaxoSmithKline Healthcare»
Медицина, фармацевтика, аптеки... Показать еще
Post the Quality assurance specialist
Duty:
• Creation and complaints handling in CRS
• Creation and deviations handling, including Carisma system
• Control for every shipment with complaint samples and follow up the manufacturing site / TPO QA for receiving investigation reports in time
• Timely reaction on requests from distributors, Health Authority, consumers regarding to declaring, normative documents, quality products on suspicion of counterfeit, also inquiries of information character
• Supervise the duty of care release activities for RU market (OTC and OHC products) according to 2 schemes to ensure products are released in CERPS in compliance with the local requirements and regulations
• Temperature control for all incoming products and management any deviations
• Monthly reporting and KPI
• Monthly reconciliation with PV team for complaints, including related to AE
• Creation trends analysis and their presentation
• Close cooperation and communication with other departments, Contractor, Hot Line, CR-center, manufacturing sites, distributors, representatives and consumers on the quality matters
• Support for local WH SOP creation
• Collecting and filling of corresponding documentation on QA processes and maintaining of archive
• Participation in different QA activities (support for GMP inspection, control the product during destruction, monitoring and assessment for test shipments with new palletization, sampling with Russian HA according to state selective control)
Декабрь 2007 — Май 2016
8 лет 6 месяцев
LLC ``Novartis Consumer Health''
Медицина, фармацевтика, аптеки... Показать еще
Post the Quality assurance specialist
Duty:
• Supervise the duty of care release activities for RU market (OTC and Animal products) according to several schemes to ensure products are released in SAP in compliance with the local requirements and regulations
• Supervise the product dossier updating in accordance to various changes, the coordination with control laboratory
• Creation and complaints handling in CRTS as certified investigator and reviewer from Russian (and Ukrainian) market and the control for every shipment with complaint samples, support in CRTS at the Region level as Superuser, TOM / TAM tickets creation
• Creation and handling of deviations / change controls in TW
• Follow up and push up the manufacturing site / TPO QA for receiving investigation reports in time
• Timely reaction on requests from distributors, Health Authority, consumers regarding to declaring, normative documents, quality products on suspicion of counterfeit, also inquiries of information character
• Support Quality Manual Implementation, Gap assessment and Global Modules authorization, local WH SOP creation
• Organization, sampling and control of examination results within the carrying out of the state selective and preliminary control by plan of Russian HA and the interaction with expert laboratory
• The preparation documentation for certification by three parameters
• Carrying out of comparison of CofAs and the normative documents for adjusting in conformity for OTC products
• Ensuring quality activities at the warehouse (the control of storage conditions, self-inspection, temperature mapping, recall handling, investigation of deviations, archiving of samples, rejected and returned products)
• Creation trends analysis and their presentation
• Monthly reporting and KPI, filling of the MOH database
• Participation in different QA activities (managing of the relabeling/promo-action/repacking processes, including the creation of specification and training action with Wh people, the creation of bilingual certificates, Market Sweep, the optimization of palletization for product to decrease the quantity of damaged goods)
Июль 2003 — Декабрь 2007
4 года 6 месяцев
The Hematological Centre science of Russian Academy Medical Science
Медицина, фармацевтика, аптеки... Показать еще
Post the leading engineer of the department of processing plasma of blood
Duty:
• Development and implementation of SOP for the virologic control stage
• Development and implementation of the validation for virologic techniques
• Carrying out of self-inspection and development of CAPA
• Entrance control and sampling of raw material according to approved procedures
• Making decision about return in case of nonconformity to required documentation
• Carrying out of the virologic control timely for raw material and finished products and samples rejection at discrepancy it to declared provider passport
• Preparation of the corresponding documentation according to approved SOP during all control stages and filling of registration journals for working measurements
• Transmission of samples and package of documents with results of the virologic control for the following analysis in control-analytical laboratory
• Tracking and order for required materials (test-systems, test tubes and so on)
• Reports conducting on service of devices and the equipment
Навыки
Уровни владения навыками
Опыт вождения
Права категории B
Обо мне
Tendency to study and receive new knowledge and skills, good communication skills, organization skills, ability to work under pressure, accuracy, attentiveness, responsibility.
Work in stressful conditions and combination some functions. Set up priorities and maintain the QA operations during absence of other QA person at country level. Planning of the working day being based on business needs.
User of personal computer (Word, Excel, PowerPoint).
English (reading, speaking, technical translation and work with document)
Высшее образование (Магистр)
2005
Высшее образование (Магистр)
Moscow State Academy of Fine Chemical Technology named auto M.V. Lomonosov.
Chemical technology and biotechnology, Masters Degree
2003
Высшее образование (Магистр)
the Moscow State Academy of Fine Chemical Technology named auto M.V. Lomonosov.
Chemical technology and biotechnology, Bachelors Degree
Знание языков
Гражданство, время в пути до работы
Гражданство: Россия
Разрешение на работу: Россия
Желательное время в пути до работы: Не более полутора часов
