T: 905.363.1182 x.257
TF: 1.877.877.5152 x.257
2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Jamie Brown is a compliance consultant with experience in a high paced, heavily regulated pharmaceutical manufacturing /distribution environment. Familiar with many regulatory acts and guidelines governing pharmaceuticals, health and safety and privacy.
Skills & Highlights
Quality Control (QCO)
- Interpretation and implementation of all regulations and guidelines surrounding Controlled Drug Substances (CDS).
- Creating and maintaining all Standard Operating Procedures (SOPs), Work Instructions (WIs) and other training material.
- Prepare regulatory submissions for licence updates, annual renewals, imports/exports.
- Generating internal and regulatory reports for the Office of Controlled Substances/ Health Canada.
- Acts as Quality and Compliance subject matter expert on site for CDS regulations.
- Completes impact assessments of corporate standards/policies against current procedures.
- Primary contact/ lead for all visits, audits, and inquiries from the Office of Controlled Substance branch of Health Canada and support to other regulatory audits, including provision of documentation and CAPA records.
- Investigates deviations in procedure, coordinating the gap analysis, providing corrective recommendations and implementing remediation actions, perform deviation and procedure gap reports and corresponding remediation reports and oversee effectiveness reviews.
- Manage documentation control process for all CDS records. Responsible for the routing of change control forms (CCF), uploading the CCF onto the documentation management system, tracking and facilitating the transition of the document to authorities.
- Coordinates gap analysis and implement remediation of CDS program procedures, reports and tracks through Trackwise.
- Close all CAPAs and DRs
- Identify opportunities to improve processes in the warehouse and CDS program and to close compliance gaps
- Develop and implement a warehouse training program
- Creating and maintaining all Standard Operating Procedures (SOPs), Work Instructions (WIs) and other training material
- Trackwise Harmony
- Honours Bachelor of Science (HBSc.), Biochemistry, University of Guelph, Guelph ON
- Health Information Management Diploma, McMaster University, Hamilton ON