Contact Information

T: 905.363.1182 x.216
F: 905.542.7981

TF: 1.877.877.5152 x.216
M: 416.319.2137

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Lead Consultant

Dawn Cotter brings to Quality & Compliance Services Inc. strong organizational skills and a proficiency in dealing with detail. Her ability to optimize systems has been a great asset to the company. She has over 10 years of experience in the pharmaceutical industry, managing day-to-day product releases and meeting/exceeding client needs.

Skills & Highlights

Quality Control Officer (QCO) Services

  • Performs drug and Natural Health Product (NHP) product release activities for various importing clients
  • Ensures all Health Canada requirements for documentation and product release are met
  • Reviews release documentation against master documents to ensure requirements are met
  • Performs efficient over-the-counter (OTC) product release, averaging under one hour per release when all documentation is in order
  • Provides ongoing QCO services for several manufacturers of Good Manufacturing Practices (GMP)-compliant products
  • Handles deviations and change controls related to releases
  • Tracks and maintains product master data base for all clients
  • Sets up documentation for new product launches
  • Assists in document presentation during routine Health Canada inspections

Technical Writing

  • Revised Standard Operating Procedures (SOPs) for QCO clients
  • Assisted in summarizing data to support stability studies of biologics for large pharmaceutical manufacturer

Project Management

  • Manages the release of up to 40 products a day
  • Utilizes Sharepoint software for obtaining product release documentation from client
  • Maintained corporate invoicing
  • Maintained ISO quality management system

Computer Skills

  • BillQuick
  • Visio
  • Sharepoint
  • Intralink

Education

  • Bachelor of Science, University of Toronto, Toronto, Ontario

Continuing Education, Career Development

  • Auditing Skills
  • Technical Writing Course
  • Fundamentals of GMP
  • Product Disposition
  • GMP Training for Importers/Distributors
  • Workplace Health & Safety
  • Outlook
  • Excel (intermediate)
  • Email etiquette