Xiangyu (Mike) Mike
Vaughan,Canada
Summary
Over 8 years' experience of working in a GMP regulated environment and working as a production team leader for more than 5 years. Expertise of APIs Global logistics and FDA requirements of importing APIs, hardworking with wonderful interpersonal skills and ability to lead a team to accomplished company goals. Proactive Production Manager successful at anticipating needs and making adjustments to schedules, materials and workflow. Ready to bring expertise to company needing hands-on, knowledgeable and resourceful leader.
Overview
10
10
years of professional experience
Work History
Production Manager
AX Pharmaceutical Corp
01.2019 - Current
- Communicating and Coordinating with all 3rd party logistic companies and custom & FDA clearing Agents to solve any issues occurred when crossing the border
- Setting up the companies shipping policy based on the cost, ETA natural of products, most importantly, The APIs exporting and importing requirements of both Health Canada and FDA
- Looking up the APIs' HTS code and FDA product code needed when exporting APIs to Unit States and determine the tariff rate applied to products
- Prepare and pack Hazmat shipments and docs based on IATA DGR
- Allocating production departments tasks and monitoring all production staff's performance to ensure the task can be completed accurately and on time
- Coordinating with QA department to ensure the entire production department can finish jobs in compliance with GMP, FDA and Health Canada regulations
- Regularly inspect the warehouse and clean room to ensure there are no violations of GMP and all equipment is working properly
- Working with US pharmaceutical distributors to deliver our products to customers in accordance with their requirements
- Calculating and control of annual production and shipping cost and reporting to CEO
- Building the relationship with logistic companies and customs and FDA clearance agency which can provide the best service to satisfy our supply chain needs.
Pharmaceutical Processing Operator
AX Pharmaceutical Corp
02.2016 - 12.2018
- Booking air line or courier service for shipment to customer, coordinating with broker to ensure products can be cleared from customs and FDA
- Maintain files of shipping records and keep customer posted with shipment tracking status
- Send shipping documents to customers as requested and maintain good relationships with customers by solving problems associated with shipping
- Handling receiving Active Pharmaceutical Ingredients from qualified manufacturer according to SOP
- Determine storage areas for incoming shipments and allocate appropriate space within warehouse
- Conducting Re-packaging and Re-Labeling Active Pharmaceutical Ingredients based on work sheet from quality department by SOPs
- Record damaged or defective items and replace them according to company policies
- Handle returns and exchanges by ensuring that reverse distribution processes are followed properly
- Ascertain that all incoming and outgoing shipments are properly labeled and that correlating documents are available with each shipment
- Compare amount and identification numbers of goods against orders.
Business Development Officer
Canada National TV INC
06.2014 - 10.2015
- Plan, development and coordinate marketing and promotional strategies and events
- Manage marketing programs to develop, market and promote reputation, images of company
- Plan and estimate budgets for promotional activities and events
- Coordinate with other departments, as well as external parties in planning, developing and execution related projects, campaigns and activities
- Design methods of measuring effectiveness of marketing and promotional strategies and activities
- Design format and contents documentation used to conduct surveys.
Education
Canadian International Freight Forwarding Association (CIFFA)
01.2021
Canadian College of Food and Health
01.2019
Humber College - Toronto, ON, Canada
01.2013
Liaoning ShiHua University - Fushun, Liaoning, China
01.2010
Skills
- Knowledge of GMP
- FDA and Health Canada APIs trading requirements
- DG shipping expertise
- Relationship Builder
- Logistic expertise
- Team leadership
- Decision-Making
- Root Cause Analysis
Languages
English
Native or Bilingual
Chinese (Mandarin)
Native or Bilingual
Timeline
Production Manager
AX Pharmaceutical Corp
01.2019 - Current
Pharmaceutical Processing Operator
AX Pharmaceutical Corp
02.2016 - 12.2018
Business Development Officer
Canada National TV INC
06.2014 - 10.2015
Canadian International Freight Forwarding Association (CIFFA)
Canadian College of Food and Health
Humber College - Toronto, ON, Canada
Liaoning ShiHua University - Fushun, Liaoning, China
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