Canpolat Sivri
Associate Global Qa Systems @BioNTech SE
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WORK HISTORY
Associate Global Qa Systems @BioNTech SE
EDUCATION
Università degli Studi di Napoli Federico II
Chemical Engineering
Ondokuz Mayıs Üniversitesi
Bachelors Degree, Chemical Engineering
ABOUT CANPOLAT SIVRI
With a solid background in the pharmaceutical industry, I have developed expertise in GMP compliance, quality management systems, and continuous process improvement. Throughout my career, I have been actively involved in deviation and customer complaints investigations, root cause analysis, risk assessments, CAPA management, regulatory, and compliance monitoring, ensuring adherence to the highest quality standards at every stage of production.I am passionate about enhancing operational efficiency, optimizing quality processes, and driving excellence in the pharmaceutical and life sciences sectors. My experience in quality assurance, regulatory compliance, root cause analysis, and data integrity enables me to approach challenges with a solution-oriented mindset, applying detailed research and comprehensive analysis to address complex issues and support continuous improvement.Key Expertise- GMP, GLP, GDP & Regulatory Compliance- Deviation & Complaint Management & CAPA Implementation- Risk Assessment & Process Optimization- Quality Management Systems (QMS)- Data Integrity & Compliance Monitoring- Internal, External, MoH Audits- CSV & Data Integrity
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