Personal information hidden

Contact information

This job seeker has hidden his personal information, but you can send him a message or suggest a job to him if you open his contact info.

Work experience

Engineer Validation of Computerized Systems

from 01.2016 to now (8 years 4 months)
Pharmaceutical business

Work with a range of computerized system like: ERP SAP, EDMS MyProcess, LIMS LabWare, IBM Maximo, BMS Siemens desigo insight, integration process with systems. IT infrastructure, SW/HW, Cloud qualification. Management of project activities and deliverables providing Regulatory Guidance regarding compliance with intended specifications. Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications. IQ/OQ/PQ Protocols, Reports, Traceability Matrix, Periodic Review, and Standard Operating Procedures, Change Control, Test Execution and Deviation Management Planning and scheduling of validation and Validation Lifecycle Deliverables.

Education

National Pharmaceutical University of Ukraine

Pharmaceutical technology of drugs, Engineer technologist, Харьков
Higher, from 2005 to 2011 (5 years 10 months)

Understanding how to produce medicines, the technology of their production and related processes.

Additional education and certificates

Validation of computerized systems, standards, methodology, practice.

2016, 1 Day

C++ tutorial course

2017, 1 month

SQL Fundamental course

2017, 1 month

Python 3 tutorial course

2017, 1 month

HTML Fundamental course

2017, 1 month

C# tutorial course

2017, 1 month

PHP tutorial course

2017, 1 month

Knowledge and skills

Language proficiencies

• Ukrainian — fluent
• Russian — fluent
• English — average

Additional information

Ability to develop and manage client relationships while identifying new opportunities. Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries. Understanding of the Computer Validation Life cycle Knowledge of GxP, GAMP, CFRs (Part 11). Communication and organization skills. Willingness to update and maintain knowledge.