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Keywords - Overview
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Competencies: |
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- Quality approach (
eCompliance) within global IT Projects
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- Legacy Review, Remediation
and Computer System Validation for Medical Device Manufacturing
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- Quality- and Risk
Management (FMEA) in validated environments
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- Compliance with FDA
21CFR11 - 21CFR820 - ISO13485 - ISO14971 - ISO 62304 - GAMP5
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Personality: |
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Interactive personality with ability to operate
effectively in an internation environment
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Strong quality focused and customer oriented
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Calm even in hectic situations
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Maturity to deal and interactt with a wide variety
of people at all levels
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Core Skills:
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- Bringing your environment to a validated
status by seriuos Quality- and Validation planing in GxP environments
with risk-based approach
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Total Quality Management Certified
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Prodisc Cervical by Synhtes |
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GCP (Good Clinical Practice) Certified
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Profound knowlwdge in FDA regulations and other
Guidelines, such as: 21CFR11, 21CFR820, ISO13485, ISO14971, ISO62304,
GAMP5, ITIL
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GMP on Medical Device manufacturing (Implants &
Instruments)
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Team Leading with very good interpersonal-,
communication- and problem solving skills
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Drug development processes, Pharmacovigilance and
drug safety
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CSV Engineer, Lead PQM, Project Manager, Quality
Manager, IT Team Manager, Senior Application Manager, IT Manager, ERP
Programmer, IT Coordinator,
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REFERENCES |
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