Резюме № 31532724
Обновлено 29 июля 2015
Обновлено 29 июля 2015
Quality Assurance & Regulatory Affairs Manager
Был больше месяца назад41 год (родился 13 июня 1984)
Москва
Занятость
полная занятость
Гражданство
не указано
Контакты
Телефон
Почта
Фото, имя и контакты доступны только авторизованным пользователям
Опыт работы 20 лет и 2 месяца
- Январь 2014 – работает сейчас
- 11 лет и 11 месяцев
Regulatory Affairs Manager
Air Liquide, МоскваОбязанности и достижения:
1. Ensuring the compliance of medical gases production sites with ISO 9001, ISO 14000, OHSAS 18001, FSSC 22000, ISO/IEC 17025, cGMP. 2. Development, management & improvement of all elements of the Air Liquide Integrated Management System (AL IMS): deviations, CAPA management, internal & external audits, change control, documents & records control, facilities management, supplier management, quality risk management, validation, qualification & calibration, returns & recalls etc. 3. Supporting Air Liquide top management on issues related to Air Liquide Integrated Management System (IMS) including trainings & quality overview reports. 4. Ensuring the compliance of marketed medicinal product portfolio to internal, contractual and legal regulations & requirements. 5. Development and implementation of regulatory strategies for assigned medical products, including labeling, submission and maintenance activities related to marketing authorization applications (MAAs), and labeling/packaging.- Апрель 2013 – сентябрь 2013
- 6 месяцев
Head of Quality Assurance Department
Russian Antidoping Agency (RUSADA), МоскваОбязанности и достижения:
1. Development & implementation of the Quality Management System in compliance with ISO 9001 & the World Anti-Doping Agency requirements. 2. Development & implementation of balanced scorecard (BSC) and key performance indocators (KPI) as a key strategy performance management tool that was used by top managers to keep track of the execution of activities by the staff. 3. Communication with public & regulatory authorities, national and international sport organizations (International and National Olympic Commitee, Sport Federations, the World Anti-Doping Agency), certification bodies on issues related to Quality Management System & Regulatory Compliance. Notes: - ------- 1. My work expericence in RUSADA was under the terms of short-term employment contract. 2. RUSADA Quality Management System was sucessfully certified by the Det Norske Veritas in 2013, approved by the World Anti-Doping Agency & International Olympic Committee and used during Sochi 2014 Winter Olympic Games.- Июль 2005 – апрель 2013
- 7 лет и 10 месяцев
Head of Quality Assurance & Control Department
Moscow Antidoping Centre (the World Anti-Doping International Testing Laboratory), МоскваОбязанности и достижения:
1. Development (from scratch), implementation, maintenance and improvement of the Quality Management System in compliance with ISO 9001, ISO/IEC 17025, GLP & the World Anti-Doping Agency requirements. 2. Management of all elements of the Quality Management System: deviations, CAPA management, internal & external audits, change control, documents & records control, facilities management, supplier management, quality risk management, validation, qualification & calibration, reports etc. 3. Development, implementation & improvement of all business-processes for Moscow Antidoping Centre (Business Process Model and Notation using IDEF0, EPC, ARIS). 4. Communication with public & regulatory authorities, national and international sport organizations (International and National Olympic Commitee, Sport Federations, the World Anti-Doping Agency), certification and accreditation bodies on issues related to Quality Management System & Regulatory Compliance. 5. Development & validation of quantative and qualitative analytical test methods used for human & equine doping control (HPLC-MS/MS; UPLC-MS/MS, GC-MS). 6. Providing supporting & trainings for empoyees and top management on issues related to quality assurance & control, analytical test methods performance and validation, other QA/QC issues. Notes: - ------- July 2005 - October 2009 - Research Felllow Position. October 2009 - November 2010 - Senior Research Fellow Position. November 2010 - April 2013 - Head of Quality Assurance and Control Department Position. Achievements: - ------------------ 1. Moscow Antidoping Centre Quality Management System was sucessfully certified by the AAC Analytica in 2013, approved by the World Anti-Doping Agency & International Olympic Committee and used during Sochi 2014 Winter Olympic Games. 2. Fifteen quantative and qualitative analytical test methods for human & equine doping control were developed under my direct management 2 (two) of which were patented and proposed by the World Anti-Doping Agency as the state-of-art methods in human doping control. 3. Insured the corporate liability of the company for $ 15 million USD (first case for corporate liability insurance for the testing laboratory in Russian Federation). 4. During the quality management system improvement process reduced procurement costs of the company for 35,6%. 5. Implemented the laboratory management system (LIMS) for the company that supported all business-processes.
Образование
- Высшее образование
- Заочная
- 2011
- Кандидат наук
- Дистанционная
- 2009
- Высшее образование
- Дневная/Очная
- 2006
Факультет: Faculty of PharmacyСпециальность: Pharmacist
Обо мне
Дополнительные сведения:
Personal skills:
- -------------------
High organizational skills; ability to make independent decisions; sociable; high level of self-organization; developed analytical skills; strategic thinking; focus on results and cost-saving; ability to work with large amounts of information; ability to work in a team and independently; commitment to continuous learning and self-improvement.
Additional information:
- -----------------------------
Windows, MacOS, Unix; Microsoft Office, Open Office, Google Business Applications, MacOS iWork, ARIS, BPWin, Business Studio, 1С version 7 & 8; StarLims, Thermo Finnigan Nautilus, Thermo Finnigan Xcalibur, Agilent Chem Station, Mass Hunter, Karat 32.
More that 15 publications related to clinical pharmacology, pharmacokinetics, analytical & forensic chemistry in russian and foreign scientific journals.
Co-author of 2 (two) patents related to laboratory analytical & test methods of analysis in human & equine doping-control.
GMP (Good Manufacturing Practice)
ISO 14001
GLP (Good Laboratory Practice)
ISO 9001:2008
OHSAS 18001
ISO/IEC 17025
FSSC 22000
Project management
Quality Management
Quality Control
Regulatory Authorities relationships
Regulatory affairs
Medical Law
Pharmacovigilance
Generic Pharmaceutical Products
Original Pharmaceutical Products
Balanced Scorecard
KPI development
Иностранные языки
- Английский язык — cвободное владение
Водительские права
- B — легковые авто
Фото, имя и контакты доступны только авторизованным пользователям
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