Bernhard Gunnesch
Quality Assurance Expert @BioNTech SE
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WORK HISTORY
Quality Assurance Expert @BioNTech SE
Leadership and support of projects as Single Point of Contact (SPOC) to optimize quality-related processes and workflows in GMP-regulated environments, collaborating with cross-functional teams such as MS & T, Production, QC, and Engineering.• Management and approval of change controls, deviations, and CAPAs, as well as review of procedural documents, reports, and forms.• Execution of QASF activities and GMP walkthroughs to ensure compliance and identify potential risks.• Support during audits and inspections as SME, including presentations and back-office service.• Development and delivery of GMP training sessions and creation of training materials.• Continuous improvement of QMS through the application of QRM principles.
EDUCATION
Hochschule Trier
Bachelor of Science - BS, Biological and Pharmaceutical Engineering
Bernd-Blindow-Schule Friedrichshafen
Pharmazeutisch-Technischer Assistent
ABOUT BERNHARD GUNNESCH
Quality Assurance expert with over 6 years of experience in GMP-regulated pharmaceutical manufacturing. Extensive expertise in deviation, change control, and CAPA management, as well as the development and optimization of QMS systems. Skilled in interdisciplinary process improvement and leading cross-functional projects with teams from MS & T, production, QC, and engineering. Strong communication skills as a Single Point of Contact (SPOC), audit experience, and in-depth knowledge of regulatory requirements (EMA & FDA guidelines, ICH standards).I am passionate about optimizing and safeguarding biopharmaceutical processes—particularly through the implementation of robust QMS systems and the digital transformation of the pharmaceutical industry. My goal is to contribute to the sustainable improvement of patient health and ensure the safety of pharmaceutical products.If you share similar interests or would like to discuss topics such as GMP, process optimization, or digitalization, I would be happy to connect and exchange ideas.Best regards,Bernhard
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