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Опыт работы

Engineer Validation of Computerized Systems

с 01.2016 по наст. время (8 лет 4 месяца)
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.

Образование

National Pharmaceutical University of Ukraine

Pharmaceutical technology of drugs, Engineer technologist, Харьков
Высшее, с 2005 по 2011 (5 лет 10 месяцев)

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

Дополнительное образование и сертификаты

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

Знания и навыки

Знание языков

• Украинский — свободно
• Русский — свободно
• Английский — средний

Дополнительная информация

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.