Michele Simone Email & Phone Number
Director, Corporate Quality Compliance, Risk Management and Continual Improvement @ Bracco
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Michele Simone Location
- Ticino, Switzerland
Michele Simone Work
- 2014 -now Director, Corporate Quality Compliance, Risk Management and Continual Improvement @
- 2014 -now Director, Corporate Quality Compliance, Risk Management and Continual Improvement @
- 2014 -2015 Responsible Person (QP) @
- 2013 -2014 Associate Director, Senior Auditor, EQ-QA, Corporate Quality Audits @
- 2011 -2013 Senior Manager, EQ-QA and Corporate Quality Assurance Audits, Senior Auditor @
- 2011 -2011 Quality Department Director at Nerpharma @ Nerviano Medical Sciences
- 2011 -2011 Qualified Person at NerPharma DS @ Nerviano Medical Sciences
- 2008 -2011 Head of Quality System and Compliance Italy @
- 2008 -2008 QA and Training Senior Manager- Parenteral Technology Platform @
- 2005 -2008 QA and QC Senior Manager @
- 2006 -2007 European Training Process Design Owner @
- 1994 -2005 QA GMP Compliance Manager @
- 1992 -1994 Environmental Microbiological Lab @
Michele Simone Education
- AIFA- Aknowledgement as Qualified Person
Qualified Person certification (Pharmaceuticals)
2007-2007 - Università degli Studi di Bari
Clinical Pathology (Applied biology and Medicine)
1992-1996 - Università degli Studi di Bari
Qualification (Biologist practice qualification)
1992-1993 - Università degli Studi di Bari
Bachelor (Biology)
1984-1992
Michele Simone Skills
- CAPA
- GMP
- Quality Systems
- FDA
- Quality Auditing
- Pharmaceuticals
- SOP
- Quality Assurance
- Quality Management
- Auditing
- Compliance
- Microbiology
- ISO
- Training
- GxP
- Aseptic Processing
- ISO 13485
- Trackwise
- Iso 9000
- Certified Green Belt
- Quality System
- Pharmaceutical Industry
- Medical Devices
- Change Control
- FDA GMP
- Biotechnology
- Technology Transfer
- Regulatory Requirements
- Validation
- R&D
- Pharmaceutics
- Regulatory Affairs
- 21 CFR Part 11
- V&V
- Computer System Validation
- GLP
- Regulatory Submissions
- Vaccines
- GCP
- Cleaning Validation
- Clinical Development
- Clinical Trials
- LIMS
- Pharmacovigilance
- CRO
- Drug Development
- HPLC
- ICH-GCP
- Analytical Chemistry
- Ich Gcp
- Coronary
- Stents
- QC
- Risk Management
- Manufacturing
- Computer System
Michele Simone Summary
- Michele Simone, based in Ticino, Switzerland, is currently a Director, Corporate Quality Compliance, Risk Management and Continual Improvement at Bracco. Michele Simone brings experience from previous roles at Bracco and Merck Group. Michele Simone holds a 2007 - 2007 Qualified Person certification in Pharmaceuticals @ AIFA- Aknowledgement as Qualified Person. With a robust skill set that includes CAPA, GMP, Quality Systems, FDA, Quality Auditing and more. Michele Simone has 2 emails and 1 mobile phone numbers on RocketReach.
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