Eva Mikysková
QA&RD specialist at COMPEX- Claim this Profile
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Bio
Experience
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COMPEX, spol. s r.o.
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Czechia
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Medical Equipment Manufacturing
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1 - 100 Employee
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QA&RD specialist
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Nov 2020 - Present
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VUAB Pharma a.s.
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Brno, Jihomoravský, Česká republika
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Quality Assurance Manager
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Apr 2011 - Oct 2020
- Responsibility for implementation of GMP principles in control of drug quality in accordance with Act No. 378/2007 - Responsibility for change management process - Responsibility for deviation management process - Responsibility for management and realization of internal and external audits. - Responsibility for documentation system. - Responsibility for releasing of input materials, intermediate products and finished products. - Responsibility for compiling of validation and calibration plan Show less
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MedChemBio
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Olomouc a okolí
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Quality Manager
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Jan 2010 - Mar 2011
- Responsibility for documentation system, creation and renewal of documentation - Responsibility for creation and improving quality assurance - Responsibility for change management system, deviations, out-of-specification results - Responsibility for proposal of corrective and preventive provisions, control of their implementation. - Responsibility for internal audits of the quality system, - Responsibility for documentation system, creation and renewal of documentation - Responsibility for creation and improving quality assurance - Responsibility for change management system, deviations, out-of-specification results - Responsibility for proposal of corrective and preventive provisions, control of their implementation. - Responsibility for internal audits of the quality system,
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Pliva_Lachema a.s.
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Brno, Jihomoravský, Česká republika
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Quality Technician of documentation
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Jan 2007 - Dec 2009
- Ensuring of production, control and management of procedures and documentation for analytical and microbilogical laboratories - Monitoring of changes in external documentation of products and processes - Implementation of these changes into internal documentation and processes. - Ensuring of production, control and management of procedures and documentation for analytical and microbilogical laboratories - Monitoring of changes in external documentation of products and processes - Implementation of these changes into internal documentation and processes.
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Education
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VUT Brno
Ing., material chemistry