Verna Rathore is a resourceful professional with top Quality Assurance training and over ten years experience in the pharmaceutical industry. Verna's dedication to detail, organizational, communication and problem solving skills were recognized in her previous management role as Quality Assurance Coordinator for Hemosol Inc. (Mississauga). In addition to quality assurance, Verna also brings considerable experience in the medical device industry and its related ISO elements. Her ability to persist in probing and evaluating information has enabled Verna to find smooth transitions in complex group and individual project work.

Management of Change Control System

• Reviewed, verified and approved Change Control documents.
• Maintained Change Control records and database.
• Wrote or revised SOPs, labels, product inserts and Change Control documents.
• Coordinated and performed inspection, inventory control and release of finished product.
• Management of Product Complaints - liaised with Clinical department in resolving complaints and coordinating corrective action.
• Management of Incident Reports - reviewed accuracy and completeness of incident reports.
• Provided training to new Quality Assurance staff.

Quality Assurance/Process & Product Development

• Prepared report summaries of Quality Assurance systems for referencing and evaluation.
• With Regulatory Affairs and Research Development designed a label for a new clinical product.
• Performed ELISA, stability, and inspection testing of reagents for medical device establishment.
• Introduced a more efficient ELISA procedure in order to reduce testing time by 50 per cent.
• Extended shelf life and approval of 60 antibodies eliminating backlog of ELISA testing.
• Assisted with internal audit for conformity to ISO 9001 element 4.15 Handling, storage, packaging preservation and delivery.
• Redesigned, developed and resolved problems of oncology diagnostic kit.
• Facilitated development of Design Control element ISO 9001 quality system for process qualification for medical device company.
• Handled 4 individual and 3 group projects to redevelop/optimize, qualify and produce diagnostic products.
• Successfully evaluated and transferred an immunoaffinity purification procedure reducing labor time and production costs.

Education

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

Continuing Education, Career Development

• Annual Product Review, PSG
• Good Manufacturing Practices
• Industrial Drug Legislation, Seneca College
• ISO 9001
• Quality Auditing, Sheridan College
• Radiation Protection
• Technical Writing Course, Q&C
• WHMIS certification