Contact Information

T: 905.363.1182 x.215
F: 905.542.7981

TF: 1.877.877.5152 x.215
M: 416.473.1451

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

Anna is a dedicated and flexible professional, with good organizational skills and an eye for detail. Supported by a background in linguistics and experience in technical writing and regulatory work in the cosmetics industry, Anna has a good working knowledge of Health Canada Good Manufacturing Practices (GMP) regulations and is able to produce quality work. Anna prioritizes and multitasks well, and has demonstrated an ability for working under tight timelines. She works effectively both independently and as part of a team.

Skills and Highlights

Technical Writing

  • Managed development, writing, and approval of standard operational procedures (SOPs), policies, and work instructions
  • Wrote deviation reports and manufacturing investigations
  • Maintained document control
  • Created and formatted document and SOP templates
  • Established a departmental technical writing guideline
  • Helped develop corporate Technical Writing Course
  • Assisted in producing a user-friendly publication of GMP regulations
  • Developed and wrote Mandatory Problem Report and Recall procedures that successfully passed Health Canada's evaluation
  • Performed technical review/proofing of business and marketing materials
  • Developed and wrote employee manuals and user guides
  • Formatted and prepared a manuscript, based on submissions by a number of authors, for publication

On-Site Consulting

  • Led and coordinated Change Controls for complex project
  • Performed manufacturing investigations and investigated deviations and non-conformances
  • Managed and advanced multiple projects through to completion

Training

  • Assisted in delivering a corporate Technical Writing course

Regulatory

  • Prepared Health Canada submission for drugs and cosmetics:
    • Category IV Drug Identification Number (DIN) Applications
    • Cosmetic Notification Forms
    • Medical Device Licence renewal applications
  • Reviewed and updated drug and cosmetic product labels for regulatory compliance
  • Responded to clarifications/questions from Health Canada within specified timeframes

Auditing

  • Prepared internal documentation for Health Canada Audit
  • Prepared responses to Health Canada audit comments
  • Prepared documentation for internal auditing

Computer Skills

  • Microsoft Office: Word, Excel, Power Point, Visio
  • Trackwise 
  • Quality eDOC
  • Familiar with SAP
  • Familiar with FrameMaker

Education

  • Master of Arts, Linguistics, York University, Toronto, Ontario
  • Honours Bachelor of Arts (Psychology and Linguistics), York University, Toronto, Ontario

Continuing Education, Career Development

  • Change Controls
  • General Good Documentation Practices
  • GMP Regulations
  • LabWare Basics
  • LabWare Sample Management
  • Manufacturing Controls
  • Reporting Failure Investigations
  • SAP Basic Navigation
  • SOP Writing
  • Technical Writing Course
  • TrackWise Corrective Action and Preventive Action Training
  • TrackWise Navigation Training
  • Audit Skills
  • WHMIS Training