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Jan 2016 - Dec 2016
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Sep 2012 - Sep 2014
GPA
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Sep 1995 - Sep 2000
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Jan 2014 - Dec 2015
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Jan 2008 - Dec 2008
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www.enhancv.com Verified by
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MICHAEL BONETT
Quality Regulatory Compliance Manager
0044 (0) 7500 70 2779 mbon008@yahoo.com
https://uk.linkedin.com/in/michael-bonett-4
022212
Europe, United Kingdom
EXPERIENCE
Quality Regulatory Manager /QMS GDP Auditor
Johnson & Johnson Medical
UK Reading Wokingham
ISO 9001:2015 Quality Management System implementation including
reviews, supplier/internal audits, quality issues and CAPAs - Track-wise
Preparation for MHRA and BSI Inspections and audits, support to RP
ISO 13485:2016 IRCA certified auditor, audited distributors and 40
medical product suppliers against GDP (medicines) ISO 13485 (medical
devices) and human tissue regulations to assure product supply quality
Designed 20 process flows and several SOPs and implemented risk
management plan for new hospital supply chain distribution business
Overseen URS and UAT of an Inventory Management System - Atticus
Training, Documentation and Change Control via TRU-Vault and Summit
Management of field safety notices/recalls, complaints, adverse events
Design of a high-quality, affordable and sustainable supply chain
On-site inventory management and delivery of licensed medicinal
products, human tissues, knee (Attune®), hip and spinal implants
Increased revenue via an innovative managed service business model
EDUCATION
Masters Marketing
University of Malta 6.00 6.00
Bachelor Pharmacy
University of Malta 6.00 6.00
ACHIEVEMENTS
Upgraded Quality System to 100%
compliance to EU GDP Guidelines
2013/C 343/01
2012 UPS Supply Chain Solutions (SCS)
Quality Lead in a project team
that set up Maltese Agency in EU
2004 Malta Medicines Authority (MMA)
LANGUAGES
English
Dutch
PROJECTS
Integration of UPS Acquisitions
UK, Italy, Hungary, Poland
Integration of Polar Speed, Pieffe, Cemelog &
Poltraf into UPS Quality Management System
Visibility and improvement in KPI reporting
Integration of J&J Companies
Leiden NL , Beerse BE
Integration of Centocor into Janssen Biologics
Increased efficiency of operational processes