Dančo Georgiev Email & Phone Number

Central Bohemian Region, Czechia

Central Bohemia, Czechia

Change management fot DeltaV Equipment modules, phases, recipes etc. – creating & testing

Prague, Cz

- IT Quality Control (for Novartis)- Change Coordinator (for Novartis)- Change Management (using Remedy on Demand)- IT Qualification activities- work under ITIL- certified Internal auditor ISO 9001:2015- certified Internal auditor ISO 27001:2013

Lonza Biotec S.R.O. Kouřim, Cz

CSV - Validation of all types of Computerized systems based on GAMP5, 21 CFR part 11 and relevant internal procedures▪CSV documentation - writing, reviewing, testing, approving▪Data Integrity auditiong▪Validation documentation creation▪Project management▪OE (operational excellence) LEAN specialist cooperated on Lonza Global level▪QA reviewing and approval of Quality Control - SOPs, Change Requests▪Deviation / Investigation handling▪Internal auditor (ISO 9001, GMP etc.)▪Area trainer for Deviations, Investigations, Root Cause classification▪Area EPS (Error Prevention System) training and coaching (Global LEAN Project)▪Finalized Green belt project for Reduction of Deviations

Kouřim, Cz

▪Core member of the Lonza´s Global OE (Operational Excellence) team for decreasing of deviations - Zero Deviation Project (A Global Lean and Quality project)▪Co-author of Global Lonza Root Cause Clasification Guide "The Lonza Root Cause Tree"▪Project management on the global level▪Green Belt training

Lonza Biotec S.R.O Kouřim, Cz

▪Coordination of project, processes, equipment, materials and people in KUP15 plant.▪Lead a production team of 14 employees under cGMP.▪Project management▪Establishing of SOP, procedures and rules.▪CSV - writing, reviewing, testing documentation▪Programming batch recipes under Siemens Simatic PCS7.▪Co-working with internal QA specialists▪Co-working with QA on FDA and SUKL audits

Lonza Biotec S.R.O., Kouřim, Cz

▪Coordination of projects, equipment and materials on KUP15 plant.▪Project management▪Yellow Belt training and certification. Responsibility for continuous improvement activities under OE (Operational Excellence) using LEAN tools▪CSV - writing, testing, reviewing documentation▪Programing of batch recipes for Siemens Simatic PCS7.▪Preparation, qualification of Simatic PCS7 phases in cooperation with QA

Kouřim, Cz

▪Lead a production team of 3-5 employees under ISO 9001 and cGMP.▪Process supervision with Yokogawa μXL, Siemens Simatic PCS7.▪Establishing of SOP, procedures and rules.▪CSV - revieving and testing documentation▪Co-working with external and internal suppliers.

Engineer'S Degree, Engineering Geology & Hydrogeology, 1987

Activities and Societies: Alen Mak group, University handball team

High School - Focused On Math And Languages, 1979

Activities and Societies: Music group