
Timeline
About me
SDS Author - Lubricants - Regulatory Compliance Delivery/Product Stewardship - Shell
Education
Ispe nasu
2014 -Doctor of philosophy (phd) physical chemistryNational university of pharmacy
2017 - 2019Master's degree quality, standardization and certificationKyiv national taras shevchenko university
2008 - 2014Master's degree chemistry
Experience
Ispe nasu
Nov 2012 - Dec 2013EngineerArterium
Jul 2013 - Dec 2013Analytical chemist (junior research scientist)1. Development, improvement and validation of analytical techniques for the GC-FID and GC-MS analysis of APIs, excipients and drug products.2. Documentation procedures and reporting results.
Arterium
Apr 2014 - May 2015Analytical chemist1. Development, improvement and validation of analytical techniques for the analysis of APIs, excipients and drug products.2. Сompilation of Module 3 in CTD format3. Documentation procedures and reporting results.4. Regular maintenance (including qualification) of laboratory equipment.5. Control of stability samples following the testing calendar by specified methods.
Yuria-pharm llc
May 2015 - Nov 2017Responsibilities:• Development, improvement and validation of analytical techniques for the analysis of drug substances, drug products, medical devices, packaging for FDP.• Compilation of Module 3 in CTD format.• Compilation of medical devices design&development dossier according to requirements of ISO 13485 and Directive 93/42/EEC, audit support. • Reviewing and agreement of reporting documentation and results.• Leadership of a team of analytical chemists. Responsibilities:• Development, improvement and validation of analytical techniques for the analysis of drug substances, drug products, medical devices.• Compilation of Module 3 in CTD format.• Documentation procedures and reporting results.• Regular maintenance including qualification of laboratory equipment.• Control of stability samples following the testing calendar by specified methods.
Senior Analytical Chemist
Feb 2016 - Nov 2017Analytical Chemist
May 2015 - Feb 2016
Arterium
Nov 2017 - Dec 2022Project managerResponsibilities:1. Manage various projects and lead the cross-functional coordination of project teams 2. Establish and manage each project schedule and budget to ensure timely completion and communicate effectively with all project stakeholders to share relevant information 3. Report project status 4. Manage project documentation
Shell
Jan 2023 - nowSafety data sheet authorResponsible for the delivery of Hazard Communication documentation to various classes of business to support Shell's license to operate. The team manages more than 130,000 documents in more than 27 languages.1. Works within the rules and processes defined for the team to identify and assemble appropriate information within the system to produce accurate safety data sheets to meet the agreed deadlines.2. Applies technical knowledge and regulatory rules to produce compliant hazard communication documentation.3. Manages stakeholders within and outside the Product Stewardship team4. Identifies and promotes Continuous Improvement opportunities to eliminate waste where possible.5. Is a primary lead for specific business areas or lines and coordinates support for that area. 6. Makes safety data sheets available to the business, ensuring on-time product delivery to customers.7. Coaches and supports others in the team within a particular area of expertise Show less
Licenses & Certifications
Good laboratory practice for pharmaceutical quality control
State training center for gmp/gdpDec 2016Modern realization of classical karl fisher water titration technique.
Alsi ltd.Nov 2016Chromatography systems. chromatography qualification. gmp in chromatography
State training center for gmp/gdpSept 2015- View certificate
Edx honor code certificate for introduction to project management
Edx - View certificate
Edx honor code certificate for principles of biochemistry
Edx Lubrication fundamentals
The lubrizol corporationMay 2023Effective project management
Leo consultingMay 2018Analytical equipment for quality control in pharmaceutical manufacturing
Alt ukraine ltdFeb 2017Kinetex core-shell technology for pharmaceutical methods and ph.eur. monograph methods
PhenomenexNov 2016
Languages
- укУкраїнська
- руРусский
- enEnglish
- poPolski
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