Andy Wang Email & Phone Number

Brampton, Ontario, Canada

· Conduct investigations on market complaints, Suspected Adverse Events (AE) and Lack of Efficacy (LOE).· Writing investigation reports.· Create and maintain monthly, quarterly and yearly metrics for complaints and deviation investigations. Analyze and compile raw data into meaningful / graphical presentations. · Presentation on trending, metrics reporting (Quality Investigation, Market Complaints and AE / LOE) in Site Quality Council Meetings.· Lead the project in the… Show more · Conduct investigations on market complaints, Suspected Adverse Events (AE) and Lack of Efficacy (LOE).· Writing investigation reports.· Create and maintain monthly, quarterly and yearly metrics for complaints and deviation investigations. Analyze and compile raw data into meaningful / graphical presentations. · Presentation on trending, metrics reporting (Quality Investigation, Market Complaints and AE / LOE) in Site Quality Council Meetings.· Lead the project in the implementation of Trackwise system as the Subject Matter Expert (SME) in Quality Investigation, CAPA and Customer Complaints Modules.· Implementation of Electronic System. Trackwise. (Design, Implementation, Functional Testing ofcomputerized Quality system. SOP writing and training) Show less

Toronto, Canada Area

• Reassessment and redevelopment of Standard Operation Procedures (SOP).• Ensure all finished products and incoming raw materials are in compliance with the Food and Drugs Regulation of Health Canada. • Release and Management of Product batches using the SAP Quality and Warehouse Management System• Design and implement new quality programs which includes designing new forms, SOPs and Training presentations.• Initiate and manage Non-conformance Reports, Contact External suppliers… Show more • Reassessment and redevelopment of Standard Operation Procedures (SOP).• Ensure all finished products and incoming raw materials are in compliance with the Food and Drugs Regulation of Health Canada. • Release and Management of Product batches using the SAP Quality and Warehouse Management System• Design and implement new quality programs which includes designing new forms, SOPs and Training presentations.• Initiate and manage Non-conformance Reports, Contact External suppliers for quality defects resolution.• Investigate and report on non-conformances.• Annual quality reports on raw material suppliers• Reconciliation of OTC Drug Products.• Coordinate with management in change-control, documentation and component specifications. Show less

Toronto, Canada Area

• Reassessment and redevelopment of Standard Operation Procedures (SOP).• Initiate and carry out Corrective Actions in the event of a deviation.• Managing Hold - Release process of in-coming and out-going products• Verification of all quality documents.• Ensuring incoming raw materials are within specification.• Internal Audit, monthly plant audit and glass audit.• Develop, maintain and control quality documents with BRC documentation standard.• Biological sampling… Show more • Reassessment and redevelopment of Standard Operation Procedures (SOP).• Initiate and carry out Corrective Actions in the event of a deviation.• Managing Hold - Release process of in-coming and out-going products• Verification of all quality documents.• Ensuring incoming raw materials are within specification.• Internal Audit, monthly plant audit and glass audit.• Develop, maintain and control quality documents with BRC documentation standard.• Biological sampling of all products and provide Certificate of Analysis for clients.• Implementation and documentation of BRC standard and relevent training for employees.• Assist in resolving quality related issues with the management and the quality assurance department.• Update Ingredient Specification, Product Specification and raw material approved supplier program.• Laboratory testing and analysis of finished products and raw material. (fat, water activity, moisture content, pH, fermentation etc.) Show less

• Daily monitoring and implementation of CCPs in accordance to the HACCP Program and the FSEP Program. • Preparation of microbe sampling for Listeria, E-coli, and Salmonella.• Key member of the Food Safety Development Team in the SQF Accreditation (Level 2). • In charge of the reassessment and redevelopment of Standard Operation Procedures (SOP) and the Packaging Material Approved Supplier Program for the SQF Audit.• Member of the Internal Audit Team for the SQF Program.• In… Show more • Daily monitoring and implementation of CCPs in accordance to the HACCP Program and the FSEP Program. • Preparation of microbe sampling for Listeria, E-coli, and Salmonella.• Key member of the Food Safety Development Team in the SQF Accreditation (Level 2). • In charge of the reassessment and redevelopment of Standard Operation Procedures (SOP) and the Packaging Material Approved Supplier Program for the SQF Audit.• Member of the Internal Audit Team for the SQF Program.• In charge of the Mock Recall Program during the Canadian Food Inspection Agency (CFIA) Section 4 Audit.• Work very closely with the Inspector In-Charge of the CFIA to implement and maintain a high quality food safety program. Show less

Honours Bachelor Of Science, Biological Chemistry Specialist

Activities and Societies: Concert Band, Chemistry Club, Chinese Undergrate Association (CUA)

Ontario College Graduate Certificate, Pharmaceutical Regulatory Affairs And Quality Operations