Lenny D.

Senior Computer Systems Validation Specialist @Bora Pharmaceuticals

Mississauga, ON, CA

Validation lead for • SaaS ERP (S/4 HANA)• SaaS Document Management System (ZenQMS)• SaaS Learning Management System (SAP Success Factors)• AWS Hosted Chromatography Data System (Empower 3 FR5)• Cloud LIMS (LabWare)• Engineering Systems• Analytical laboratory systems• Validated Spreadsheets• Deployment of systems was performed over a 9-month period with major systems deployed within 6 months.• Designed risk-based approaches to validation strategy for agile deployment of GxP systems• Designed validation document templates• Authored local standard operating procedures for computer systems validation• Authored validation master plans, test plans/protocols/reports, GxP Assessments, Risk Assessments, vendors assessments, migration protocols, configuration specifications, interface testing protocols• Managed multi-system validation deployments ensuring that validation of GxP systems was performed to meet regulatory expectations• Regulatory inspection subject matter expert for computer systems validation

American Society for Quality

CSQE, Software Quality Engineer

York University

BSc., Chemistry and Math

Academy of Realist Art

Fine Art, Classical Realism

Ryerson University

Quality Assurance Certificate, Quality Assurance

Ryerson University

Human Resources Management, Human Resources Management

Schulich School of Business - York University

Certificate in Business Skills for Managers