Contact Information

T: 905.363.1182 x.219
F: 905.542.7981

TF: 1.877.877.5152 x.219
M: 416.357.0907

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

Verna Rathore is a resourceful professional with top Quality Assurance training and over 20 years experience in the pharmaceutical industry. Verna's dedication to detail, organizational, communication and problem-solving skills were recognized in her many previous management roles. In addition to quality assurance, Verna also brings considerable experience in the medical device, biologics, Natural Health Products (NHP), and dietary supplement industries. Her ability to persist in probing and evaluating information has enabled Verna to find smooth transitions in complex group and individual project work.

Skills & Highlights

Quality Assurance/Quality Control (QCO)

  • Worked as site Quality Assurance releasing pharmaceuticals, NHPs, and dietary supplements for use
  • Coordinated and performed product inspection, inventory control, and release of finished product
  • Coordinated the collection, review, and organization of master production documents, test methods, and product specifications from global sites of imported drug products
  • Initiated the implementation of quality system setup
  • Managed change control, product complaints, and non-conformances
  • Prepared report summaries of Quality Assurance systems for referencing and evaluation

On-site Consulting

  • Prepared for and assisted in Health Canada audits
  • Assisted in new drug product launch by coordinating the method transfer from US to Canadian laboratories
  • Reviewed and approved laboratory testing performed in-house and by third-party laboratories
  • Reviewed and approved for Quality Assurance and Regulatory Compliance of clinical and non-clinical study reports
  • Performed internal audit for conformity to ISO 9001
  • Facilitated development of ISO 9001 Design Control element for process qualification for medical device company
  • Handled individual and group projects to resolve problems, redevelop, optimize and/or qualify oncology diagnostic products
  • Successfully evaluated and transferred an immunoaffinity purification procedure reducing labour time and production costs

Regulatory

  • Managed Annual Drug Establishment Licence renewal
  • Prepared company NHP Site Licence Application
  • Prepared Cosmetic Notification Forms
  • Designed a new clinical product label with Regulatory Affairs and Research Development

GMP Training

  • Provided Standard Operating Procedure (SOP) training
  • Provided document review training of batch documents

Technical Writing

  • Coordinated the development, writing, review and approval of SOPs, ensuring that all complied with Good Manufacturing Practices (GMP) and Current GMP (cGMP) requirements
  • Developed Quality Plan
  • Developed, revised, and updated packaging specifications and product specifications for complex pharmaceutical products
  • Developed Lot Release Protocol templates for biologics product in support of the lot release program to various agencies
  • Wrote and revised SOPs and test methods

Computer Skills

  • SAP
  • LIMS
  • Documentum
  • PeopleSoft
  • Kintana
  • Visio

Education

  • Bachelor of Science, Chemistry-Biochemistry Specialist, Mathematics Minor, University of Toronto, Toronto, Ontario
  • American Society for Quality Control (ASQC) Certificate, Quality Assurance

Continuing Education, Career Development

  • Fundamentals of Regulatory Affairs
  • Industrial Drug Legislation
  • Good Manufacturing Practices
  • Annual Product Review
  • ISO 9001
  • Quality Auditing
  • Technical Writing Course
  • Radiation Protection
  • Workplace Health & Safety
  • WHMIS certification