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Candidate
Female, 35 years, born on 20 October 1989
Borovsk, willing to relocate (Belousovo, Obninsk), prepared for business trips
Clinical research associate
Specializations:
- Sales manager, account manager
Employment: full time
Work schedule: full day
Work experience 13 years 9 months
August 2020 — currently
4 years 9 months
LLC Hemofarm
Validation specialist
Planning for the process validation and cleaning validation, development of protocols and reports for process validation and cleaning validation, support of validation. Conducting a risk analysis to identify critical parameters of the production process. Implementing continuous process verification
production. Statistical analysis of production process parameters from stability and reproducibility of the process (indices Cpk Ppk, control maps).
Hard skills:
EU GMP Annex 15.
Risk assessment.
Preparation of validation documentation.
Knowledge of the technology for the production of solid form drugs.
Knowledge of the packaging process.
Planning of the validation process.
Coordination of production and QC department during validation.
April 2017 — July 2020
3 years 4 months
LLC AstraZeneca Industries
Chemist
Performing quality control tests of finished products and raw materials in accordance with the requirements of regulatory documents. Support from the quality control department of the process of launching production of new products, conducting laboratory investigations, investigating deviations from standard procedures. Transfer of analytical methods of analysis.
Hard skills:
Work according to GLP and GMP.
Development and implementation of standard operating procedures and analytical procedures.
Validation of analytical methods and qualifications of laboratory equipment.
Analytical tansfer.
Investigation of deviations.
Developing and implementing CAPA.
Risk assessment.
Сonducting a weekly audit in the QC laboratory.
Implementation and practical use of LEAN tools and 5S in routin work of QC lab.
Employee training on standard operational and analytical. procedures
February 2017 — March 2017
2 months
CJSC Partner-M
Analyst chemist
Sampling of raw materials and finished products, performing tests of incoming quality control of raw materials (moisture content, ash content, nitrogen content, fat content).
It was a short period of working experience to understand the difference in work between a research laboratory and a quality control laboratory at production.
August 2011 — February 2017
5 years 7 months
Research Institute of animal physiology, biochemistry and nutrition
Research assistance
Studying the metabolism of nitrogen and carbohydrates in ruminants, studying the effect of stress on the growth and productivity of farm animals and birds, studying the functions of the antioxidant system in the function of nonspecific immunity and stress resistance of animals.
Hard skills:
Organization and conduct of scientific experiments on animals.
Development and peformance of laboratory analysis methods.
Collection, interpretation and statistical analysis of experimental data.
Search and collection of information in international scientific databases.
Writing reports on the research work, writing scientific articles.
Public speaking at conferences.
Skills
Skill proficiency levels
Driving experience
Own car
Driver's license category BAbout me
Achievements:
Implementation of a ongoing process verification at LLC "Hemofarm" in 2021
Leading a LEAN project to reduce the lead time QC release at LLC "AstraZeneca Industries" in 2019.
Giving a Ph.D. thesis for the degree of candidate of biological sciences in the specialty - 03.01.04 - biochemistry in 2014.
Laureate of the A. L. Chizhevsky regional scholarship in 2014.
Winner of the program supporting commercially oriented scientific and technical projects of young researchers (UMNIK) in 2012, direction Biotechnology.
Soft skills: сommunication, analytical mindset, responsibility, hungry to learn, discipline, self-development, open for new information.
Hobbies: gardening, painting
Higher education (PhD)
2014
Post-graduate, Biochemistry
2011
Obninsk institute for nuclear power engineering (OINPE)
Natural sciences, Biology
Languages
Citizenship, travel time to work
Citizenship: Russia
Permission to work: Russia
Desired travel time to work: Doesn't matter