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Thomas Buraczewski
Quality Compliance Leader
Thomas Buraczewski is an experienced professional with expertise in Quality Management System (QMS) Design, Implementation, and Maintenance.
His skills include Strategic Quality Planning, Risk Assessments, Management Reviews, Product Release, Complaint Handling, CAPA, Deviation Management, and Quality Standards and Procedures.
Thomas also specializes in Root Cause Analysis, Investigations, Continuous Improvements, Annual Product Reviews, Change Management, and Critical Issue Assessments.
He has experience in Escalation and Health Authority Notifications, Product Recall, Artwork and Labeling, Regulatory Submissions, and Health Authority Inspection Support.
With a background in Global Project Leadership, Thomas has worked in Clinical, Commercial, and Contract Manufacturing, Packaging, and Logistics of BioPharma Products and Medical Devices.
His expertise extends to Quality System Auditing, Quality Metrics, KPIs, Trend Analysis, Product Stability Programs, and Computerized System Life Cycle Management.
Thomas Buraczewski holds qualifications as a US and EU Pharmacist, with BS and MS degrees in Pharmaceutical Sciences. He is proficient in Lean Six Sigma, GMP, GCP, GLP, GVP, ICH, ISO, Documentum-based eDMS, LMS, SAP, TrackWise, and SumTotal. Additionally, his native language is German.
