Contact Information

T: 905.363.1182 x.244
F: 905.542.7981

TF: 1.877.877.5152 x.244
M: 416.294.2873

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Manager Quality Services

Allison is an experienced quality assurance professional with over 18 years in the pharmaceutical industry. She is a skilled Quality Control Officer, technical writer, and auditor. Her project management skills have generated increased compliance and improved efficiencies for a number of clients. Allison is a valued team member who can also work independently as needed to move a project forward.

Skills and Highlights

Quality Assurance/Quality Control Officer (QCO)

  • Co-hosted Health Canada GMP, GVP and Medical Device Audits
  • Co-hosted Client Corporate Audits
  • Released Imported Pharmaceuticals and Biologics to the Canadian market from Mutual Recognition Agreement (MRA) and non-MRA countries
  • Coordinated product testing
  • Approved Technical Product Complaints
  • Amended Quality Agreements to align with current practice
  • Produced, reviewed, and approved Annual Product Reviews for pharmaceuticals and biologics:
    • Compiled and reviewed data for complaints, deviations, changes, validation, manufacturing, packaging, actives, raw materials, stability, analytical testing and critical in-process parameters
    • Identified trends and made recommendations on course of action
    • Performed statistical analysis to determine process capability
      • Ensured compliance of processes with Current Good Manufacturing Practice (cGMP), Certified Product Information Documents (CPIDs), Registered Technical Documents (RTDs), and current Canadian, U.S., Rest of World and Global Corporate requirements
  • Initiated, investigated, and determined corrective and preventative actions for deviations and non-conformances
  • Reviewed global change controls to access local impact
    • Conducted reviews of executed and non-executed master manufacturing and packaging documentation and annual stability for pharmaceuticals and sterile biologic drug products

Auditing

  • Conducted 3PL warehouse, laboratory and self-inspection audits to ensure adherence to Health Canada and corporate quality standards
    • Prepared Inspection Reports

Regulatory

  • Submission of Division 1 Drug Applications and Labelling Standard Drug Applications
  • Performed Drug and Natural Health Product (NHP) product label reviews
  • Filed NHP Product License Application (PLA) amendments and notifications
  • Submission of New Substance Notifications

GMP Training

  • Conducted training on new and revised Standard Operating Procedures (SOPs)
  • Trained and coached analysts on laboratory procedures

Technical Writing

  • Created and revised SOPs, Product Specifications and Forms

Computer Skills

  • Excellent knowledge of SAP
  • Proficient in Trackwise, LIMS, Statistica, various eDocs applications, Word, Excel and Powerpoint

Education

  • Bachelor of Science, Honours Applied Microbiology, University of Guelph, Guelph, Ontario

Continuing Education, Career Development

  • Auditing and Regulatory Inspections
  • Computer Validation
  • Conducting Annual Product Reviews
  • Fundamentals of Regulatory Affairs
  • GMPs for Lab Personnel
  • Microbiological Auditing
  • Technical Writing
  • Formal computer training and refresher training in SAP, Trackwise, LIMS, Statistica, various Edocs applications, Word, Excel, and PowerPoint