Tetiana Bruksha Email & Phone Number

Украина Киев

- Development and implement a quality management system (QMS) in the company.- Development and management of software quality assurance processes.- Websites and Web applications testing (cross-browser testing, UI testing, functionality testing, mobile testing).- API testing (Postman). - Development and approval of QMS/QA documentation: Standard operating procedures (SOP), Work Instructions, Templates, Tech Tasks, Test strategy, Test Plans, Test Cases, Checklists, Bug reports, Test Reports, etc.

- Web application testing (cross-browser testing, UI testing, functionality testing).- Performance/load testing (Postman, JMeter). - API testing (Postman, MySQL).- Conducting automatic tests (Java) and evaluating the results obtained- Building dynamic/static containers, creating and removing dumps of containers (Jenkins) - Writing testing documentation: Test Cases, Checklists, Bug reports (TestRail)

Ukraine, Kyiv

- Development, coordination and approval of validation documentation: Validation Master Plans, Validation protocols, Test Plans, Check-lists, Reports on defects and failures, Validation reports.- Organization and control of Qualification/Validation at the enterprise: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Qualification of Utilities, Process Validation/Verification (PV), Cleaning Validation (CV), Aseptic filling testing (MFT), Validation of Computerized Systems, Verification of Transportation, Cold chain.- Participation in the development of User Requirements Specification (URS), Functional Specification (FS).- Coordination of FAT, SAT tests.- Development of standard operating procedures (SOP), risk analysis (FMEA, HACCP), analysis of statistical data to confirm the stability and reproducibility of processes, etc.- Participation and successful completion of Ukrainian and foreign certifications of the enterprise (GMP, Anvisa) from 2015 - 2020 years.- Staff training, participation in internal audits.

Ukraine, Boryspol

- Development and coordination of validation documentation.- Conduct and control of validation of injection products, tablets, capsules and suppository. Conduct and control of Media fill test (process simulation test procedures).- Conduct and control of cleaning validation on production.

Kiev

- Development and approval of validation documentation.- Organization and control of process validation in Arterium Corporation (OJSC Kyivmedpreparat and JSC Halychpharm).- Staff training, organization and control of tasks, participation in internal and external audits, statistical processing and analysis of data, etc.

Kyiv

Development, coordination and approval of validation documentation. Organization and control of process validation, MFT, cleaning validation, etc.Received an appreciation from the Shevchenkivska District State Administration in Kyiv.

Kyiv

Development of validation documentation (qualification of cleanroom, process validation, cleaning validation), validation tests, etc.

Specialist, Industrial Biotechnologist, Biochemical Technologist

Bachelor, Chemical Technology And Engineering