Kelvin Koon Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Deviation Management – Lead investigations for deviations via collaboration with key stakeholders across site to determine investigation scope, perform root cause analysis, and complete investigation reports.Corrective and Preventive Actions (CAPA) – Collaborate with stakeholders across site to develop corrective/ preventive actions to address root causes.

Toronto, Ontario, Canada

Change Control Management – Act as a change control leader to manage any project related change control requests (CCR).GxP Document Update & Review – Provide updates to production related SOPs and GxP documents, and collaborate with key stakeholders to ensure timely review and approval.Project Management – Create and manage Bulk manufacturing related.

Toronto, Ontario, Canada

Production Management – Acted as a member of the Bulk Manufacturing APT on customer site (Sanofi Pasteur) to execute production schedules, and coordinate all shop floor activities to ensure production and project timeline adherence. Production Schedule Execution - Work with supply chain and the supporting teams weekly to plan commercial batches and verify.

Mississauga, Ontario, Canada

Certification – Completed course “Coriolis Flowmeter – Level 1” Training with Micro Motion in Colorado.Solution Recommendation – Reviewed process data specifications and performed calculations to recommend optimum instrumentation solutions for over 10 industries based on application needs. Project Coordination – Coordinated projects up to $500K and acted.

Mississauga, ON

Provide Staff Training:Co-led NW regional instructional training sessions to implement standardized practices on behavioural management and professional communication.Team Management:Managed teams of up to 10 swim instructors to ensure high quality standards in all lessons provided.Productivity Improvement:Developed and maintained a data tracking tool.

North York, ON

Equipment Calibration – Executed preventive maintenance and calibration work orders (WO) on all production and sanitary instruments in accordance to the current SOPs to support scheduled shutdowns and CAPA developments.Process Development – Created Bill of Material (BOM) on all consumable materials for the department in SAP to increase supply re-ordering.