Особисті дані приховані

Контактна інформація

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Досвід роботи

Engineer Validation of Computerized Systems

з 01.2016 по нині (8 років 3 місяці)
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.

Освіта

National Pharmaceutical University of Ukraine

Pharmaceutical technology of drugs, Engineer technologist, Харьков
Вища, з 2005 по 2011 (5 років 10 місяців)

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

Додаткова освіта та сертифікати

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

Знання і навички

Знання мов

• Українська — вільно
• Російська — вільно
• Англійська — середній

Додаткова інформація

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.