Sam Marchitto Email & Phone Number

Australia

Laverton

• Developed, implemented, maintained and monitored the Quality Management System.• Advised on and reviewed the appropriateness of systems, procedures, planning and documentation for the development and manufacture of Investigational Medicinal Product.• Approved all quality related documentation.• Safety Officer• Management of Scheduled Drugs

• Various QMS projects

• Developed and delivered GxP classroom training programs including GMP Induction and Problem Solving Approach workshops• Maintained GxP elearn modules to ensure currency and alignment with Quality Systems Policies and Global Quality Policy

• Participated in TGA & FDA audits • Developed and delivered GxP classroom training • Maintained local Quality Procedures to align with Global Quality Policies including CAPA, Deviations, Change Management and GxP Training• Created and updated GxP elearn scripts and modules• Coordinated the development and implementation of cross functional Quality Projects including GxP training, Global Documentation and Global intranet• Facilitated Quality forums including Quality… Show more • Participated in TGA & FDA audits • Developed and delivered GxP classroom training • Maintained local Quality Procedures to align with Global Quality Policies including CAPA, Deviations, Change Management and GxP Training• Created and updated GxP elearn scripts and modules• Coordinated the development and implementation of cross functional Quality Projects including GxP training, Global Documentation and Global intranet• Facilitated Quality forums including Quality Management System improvement team and Document Controllers development group • Reviewed and Updated Site Master files for Parkville and Broadmeadows facilities• Managed Good Documentation Practices and Root Cause Analysis/Investigation training Show less

• Project team leader for electronic document records and archive management system project- Managed 40 Department representatives through periodic meetings, delivery of tasks and monitoring of progress - Managed project deviations- Delivered presentations and demonstrations to Department representatives, broader department groups and Management• Designed and delivered Change Management program• Coordinated User Acceptance Testing• Facilitated the training needs of the… Show more • Project team leader for electronic document records and archive management system project- Managed 40 Department representatives through periodic meetings, delivery of tasks and monitoring of progress - Managed project deviations- Delivered presentations and demonstrations to Department representatives, broader department groups and Management• Designed and delivered Change Management program• Coordinated User Acceptance Testing• Facilitated the training needs of the business as Training Lead • Developed and implemented system reports • Wrote and maintained system documentation• Supported upgrades to software• Chaired Continuous Improvement committee and maintained Issues register• Team member of Lean Six Sigma project• Health and Safety Representative Show less

Australia

Change Control Coordinator Documentation Officer

Education record

Graduate Diploma of Science (Good Manufacturing Practices) Diploma of Business (Frontline Management) Certificate IV in Assessment &.

Bachelor Of Biological Science