Business Analyst / QA Engineer

Experienced professional with practical management experience in corporate pharmaceutical regulated industry and experienced in Quality Assurance working within software industry. ISTQB Test Manager and Scrum Master certified. Has knowledge of SAS programming (Base SAS, SAS/Macro, SAS/SQL, SAS/STAT).

Supporting, writing, reviewing and approving qualification, validation deliverables, i.e. Change Request, Validation plan, Risk Assessment; User Requirement, Functional Specifications, execution of various levels of validation protocols (OQ/PQ); creation, review of Validation/Change Reports for implementation of new FDA-regulated clinical trial management systems (CTMS), changes to existing EDC.

Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and international regulations such as 21 CFR Part 11, GAMP5 and proven practical application

Knowledge of regulatory requirements and drug development process

Understanding of FDA 21 CFR 820, ISO 13485

Reviewing, assisting in developing standard operating procedures (SOPs)

Interested in statistical programming techniques and standards, such as CDISC SDTM and ADaM.

Advanced IT QA testing background with professional experience in test methodologies, test processes, developing test schedules, implementing best practices with combined business analysis experience (requirements elicitation, documentation, validation, negotiation).

Build QA processes on the project from scratch including interview, hiring, performance review, career development. Developing, conducting trainings and mentoring team members.

Designing, review, implementing test strategies, test plans, functional, system, regression test cases, E2E tests, UAT organizing with end-users, report on test activities.

Experience working with cross-functional international teams (EU, USA, Asia) with product development, stakeholders, support roles to deliver quality product on schedule.

Able to interact professionally with a group of stakeholders, including senior executives, managers on all levels of organization.

Testing, Test Planning, System Testing, Manual Testing, SDLC, Regression Testing, Quality Assurance, Requirements Analysis, Software Documentation, Test Cases, Software Quality Assurance, Scrum, User Acceptance Testing, Test Strategy, Software Project Management, Agile Testing, Validation, Release Management, Agile Project Management, Project Management, JIRA, Quality Center, Microsoft SQL Server, SQL, Management, Team Leadership, Electronic Data Capture (EDC), Standard Operating Procedure (SOP), Clinical Trial Management System (CTMS), Microsoft Dynamics AX

Ukrainian (native), Russian (native), English (advanced)