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Was more than two weeks ago

Female, 43 years, born on 30 September 1982

Moscow, not willing to relocate, prepared for business trips

ISO 9001 manager

1 300  in hand

Specializations:
  • Sales manager, account manager

Employment type: full time, part time, project work/one-time assignment

Work experience 20 years 6 months

July 2020currently
5 years 11 months
Cosmetics company JSC Modum-nasha cosmetika
Head of regulatory department
SOP development for cosmetics GMP; Development the program of internal audits; Carrying out internal audits; Choosing outsourcing laboratories in accordance with GMP standard; Confirmation the compliance of cosmetic products with the requirements of TR CU 009; State registration of products for children TR CU 007; Confirmation the compliance of the package with the requirements of TR CU 005; Development of technical specifications for products. Development programs of researches for the confirmation of compliance. Organizing new products researches in accredited laboratory. Composing PIF for products that are exported to Europe. Obtaining gtin13, ITF14. Checking the labeling for compliance with the established requirements.
January 2020March 2020
3 months
Pharmaceutical company

Logoysk

Head oh laboratory
Preparing of the laboratory for accreditation in accordance with GOST ISO / IEC 17025-2019: development of procedures and policies in accordance with this standard, modification of existing procedures and quality guidelines; Check quality control protocols of drugs (a part of batch file); Сonducting self-inspections; QMS laboratory effectiveness assessment;. Development of measures to improve and increase the effectiveness laboratory QMS; Taking part in investigations and development of CAPA, monitoring its performance and efficiency.
June 2018October 2019
1 year 5 months
Pharmaceutical company

Moscow

Analitical QC head
Organisation of laboratorian activity according to ISO 17025; Obtaining declarations of conformity TR CU 009; Development of technical specifications for new products; Development industrial and laboratorian SOP and instructions in accordance with GMP and ISO 9001 standards; Development CAPA, monitoring its performance and efficiency; Management staff of the analytical laboratory; Development of External training plans for staff ; Supplying of laboratory with reagents and standard samples; Approval cosmetic products labeling; Metrological maintenance of laboratory equipment Preparing product files for state registration of (cosmetics) and medical devices; Working with outsourcing organizations State registration of food supplements( in Belarussian Ministry of healthcare department)-additional job
November 2017April 2018
6 months
Сertification body

Minsk

Head of Belarusian department
State registration of food supplements; State registration of veterinary medicines through Belarus; Development of technical specifications for veterinary medicines; Confirmation of products compliance with the requirements of TR CU 021, TR CU 022, TR CU 005, TR CU 017 for importers and manufacturers of Belarus and Russia (Declararions of conformity ); Development and registration of Technical specifications for cosmetics, food supplements etc. Development ISO 9001 procedures for clients for further certification. Development laboratory center project for the for the researches of food products for confirmation of compliance with the requirements of TR CU 021, TR CU 033, TR CU 024 and ND (selection the equipment, and counting of total price, selection of methods of control, layout of premises); State registration of products within the CU ( obtaining CSR) for Russian companies through Minsk.
June 2016February 2017
9 months
Food company

Moscow

Food Products... Show more

Head of laboratory/Regulatory specialist
Development schemes of chemical and microbiological control; Supplying the Laboratory with necessary equipment, materials and reagents; Preparing laboratory for accreditation according to ISO 17025 standards; Development specifications for raw materials and ready made products; Development of technical specifications for new products; Obtaining declarations of conformity TR CU; Obtaining Kosher certificate; Development information for customers (ingredients, nutrition facts etc) for Russian Federation, Germany, Lithuania, Latvia, Belarus, USA, Canada, China, South America.
July 2015June 2016
1 year
Pharmaceutical company

Minsk

Medicine, Pharmaceuticals, Pharmacies... Show more

QA manager / Regulatory specialist
Development GMP documentation in accordance with WHO and ICH guidelines and local standards. Implementation and maintenance of the GMP; Conducting self-inspections; Development of CAPA programs, monitoring performance and efficiency; Carrying out the procedure of registration for food supplements and veterinary medicines. Development of technical specifications for new products.
February 2013July 2015
2 years 6 months
Brewary

Minsk

Food Products... Show more

Head of laboratory / Regulatory specialist
Design and development laboratory from 0; Supplying the industrial laboratory with necessary equipment, materials and reagents; Preparing laboratory for accreditation according to ISO 17025 standards; Chemical control of beer (finished product: spirit content and content of dry substances in initial wort, actual extract, acidity, color) and preparation of Quality certificates; Chemical control of wort; Chemical control of raw materials; Carrying out the procedure confirmation of compliance of beer and raw materials with requirements CU TR; Development of technical specifications for new products.
February 2011February 2013
2 years 1 month
Pharmaceutical company

Medicine, Pharmaceuticals, Pharmacies... Show more

Quality control and Regulatory specialist
Incoming control of API, raw materials and packaging; Calculating the quantity of API, raw materials and packaging necessary for the technological process; Technological parameters control ; Chemical checking of finished veterinary medicines and dietary supplements (active substance identification and content such as chlorhexidine bigluconate, Vitamine A, quaternary ammonium compounds, etc.) using high perfomance liquid chromatography, spectrophotometry, etc.; Development and validation of analytical methodics dietary supplements for human and veterinary medicines analysis using USP, Eur.Ph. methods of analysis; Development of technical specifications for veterinary medicines and food supplements for human; Development of technical conditions for veterinary medicines; Carrying out the procedure of certification for dietary supplements and veterinary.
February 2009February 2011
2 years 1 month
Pharmaceutical company

Minsk

Medicine, Pharmaceuticals, Pharmacies... Show more

Quality director
Development GMP documentation in accordance with WHO and ICH guidelines and local standards. Implementation and maintenance of the GMP; Conducting internal audits and inspections and Reporting; Development of corrective action programs, monitoring performance and efficiency Development of technical specifications for the dietary supplements; Development of technical documentation; Development of analytical methods for drugs and food supplements; Carrying out the procedure of certification for finished products.
July 2008February 2009
8 months
Cosmetics and Perfumery Company

Minsk

FMCG (non-edible)... Show more

Quality manager
Development of technical specifications for the cosmetics; Development of technical documentation; Development of quality control methods for cosmetics; Carrying out the procedure of certification cosmetics and perfumery; Development of ISO 9001 documentation, implementation of QMS, certification and maintenance; Сonducting self-inspections; QMS effectiveness assessment;. Development of measures to improve and increase the effectiveness laboratory QMS; Taking part in investigations and development of CAPA, monitoring its performance and efficiency.
April 2007July 2008
1 year 4 months
Pharmaceutical company

Minsk

Medicine, Pharmaceuticals, Pharmacies... Show more

Processing Engineer
Transfer of the technology of hydrogel wound dressings production and adjustment technological process; Incoming control of raw materials and packaging; Calculating the quantity of reagents for the technological process of hydrogel wound dressings production; Control of technological parameters hydrogel wound dressings production; Maintenance the routine process documentation and records. Making progress more fast and cheap.
August 2004January 2007
2 years 6 months
Food company

Minsk

Food Products... Show more

Microbiologist
Control of sanitary conditions of production; Microbiological control of finished dairy products (identification and defining content of lactic acid bacteria in products, defining CFU, coliforms, pathogenic microorganism Salmonella, Staphylococcus); Microbiological control of raw materials and products during technological process; Carrying out the accreditation of microbiological laboratory. .

Skills

Skill proficiency levels
Analytical chemistry, Carrying out ptocedure of certification of food products and clothes
Точность и внимательность к деталям
Пользователь ПК
Стратегическое мышление
Ведение переговоров
Работа в команде
Аналитическое мышление
Организационные навыки
Английский язык
Умение принимать решения
Умение планировать
Многозадачность
Творческое мышление
Teamleading
MS Word
Project management
GMP (Good Manufacturing Practice)
Laboratoty control
ISO 9001:2008
Сертификация
ТР ТС
ISO 17025
GMG
разоаботка СОП
Regulation 1223
PIF files development
European Regulation

About me

All necessery documents for work in RF I have. PROFESSIONAL SKILLS: Strong analytical skills. Ability to handle any modern laboratorian equipment. PERSONAL SKILLS: Ability to make decisions alone. Ability to maintain effective communication with personnel of all levels. Ability to work in team. Easygoing, sociable and able to effective work in dynamic and multicultural environment.

Higher education

2011
Higher education
Belarusian State Institute of Retraining
Standardization, certification and quality management, Standardization,Certification Engineer and Quality Manager
2004
Higher education
Biotechnology, Processing engineer, chemist, microbiologist

Languages

Russian — Native

English — C1 — Advanced

Professional development, courses

2021
PharmOut limited
Online GMP training PharmOut company, Remote auditing, certificate
2021
PharmOut limited
Online GMP training a PharmOut company, GMP. Regulatory compliance (EU, USA, Australia), certificate
2021
Bureau Veritas
Bureau Veritas, 22716:2007 COSMETICS-GMP- Guidelines on Good
2020
ISO/IEС 17025:2017 Implementation and internal audit
KI, Internal audutor, Laboratory QS QM
2010
QA in accordance with GMP
Center Lotius
2005
Requirements for the organization of work with pathogenic biological agents of III - IV groups
Belarusian Medical Academy of Postgraduate Education

Citizenship, travel time to work

Citizenship: Belarus

Permission to work: Belarus, Russia

Desired travel time to work: Doesn't matter