Michael Green

Background

About Michael Green

Quality Management Systems * Trained Lead Quality Auditor ISO 9001:2015 * Trained QA Facilitator for Quality Risk Management and help with Management of QRM.* Provided Yearly Validation Record Reviews for each equipment line on Site.* Technical Report Writing and SOP Authoring for site * Provided Quality review/approval for all GMP documentation for Site.* Authored/ negotiated Quality Agreements and Manage the Quality Agreement process for site.* Helped facilitate Internal and External Audits (FDA, MHRA.etc)* Provided the Site Quality Metrics for Site Quality Review Team Monthly meetings for Havant in a PowerPoint presentation * Maintenance of Quality Procedures, Work Instructions and Manuals Documents and Records QC Records, Product certifications, test and inspections records are maintained in accordance with requirements stipulated in the Quality Management Systems.* Helped facilitate the upkeep of the site Change Control process by providing Pre approvals, Approvals and Closures, for any action items or any Change Controls that occur from the Change Control Committee Meetings that take place on a bi-weekly basis.* Daily administration and co-ordination of Quality Assurance and Quality Control Inspections - Overseeing,Goods Inwards Inspection of Safety Critical components.* The Site Matter Expert for Keyence Image Dimension System which incorporates the programming, Calibration and Validation.* Continuous improvement (Yellow Belt) using Lean Enterprise and associated Lean Tools * SharePoint 2010 Administrator/ creator * Data Analytics *Compliance Management * Regulatory Compliance * Team Work * Technical Compliance * Internal Auditing