Rachel is a highly qualified Quality Assurance/Quality Control professional with over 15 years in the Canadian pharmaceutical industry plus prior international experience. With her extensive managerial expertise and knowledge of manufacturing compliance and quality control, she enhances our Q&C^® team capabilities. She works well without guidance, and also as part of a team. Rachel is a very capable, well-organized individual who is used to working through quality and procedural issues to find effective solutions that meet regulatory guidelines.

• Managed the quality department and GMP compliance for a Canadian facility for a multinational pharmaceutical manufacturer, resulting in successful regulatory inspections and customer audits, while allowing for continuous product introduction and company growth.
• Performed review and final approval of new and revised company documentation (procedures, specifications, protocols, etc.) to ensure compliance with regulatory requirements and corporate policies.
• Established and maintained a Change Control system that tracked and justified all changes to company documentation.
• Managed release of batches to market following appropriate testing and review of batch documentation.
• Participated in the introduction of 50 new products to a pharmaceutical facility over a 5-year period, while ensuring all appropriate validation, testing, and stability requirements were met prior to launch. Played a key role in managing corporate growth (e.g., in personnel and required documentation) at the same time.
• Managed stability program for Canadian pharmaceutical company.

Auditing

• Hosted and led preparation for bi-annual Health Canada and FDA audits, resulting in a HPFBI compliance rating and successful FDA pre-approval inspections.
• Co-hosted and supported numerous audits for third-party manufacturers.

cGMP Training

• Trained department personnel in QA procedures.

• B.Sc. (Chemistry Major), University of the Witwatersrand, South Africa

• Advanced GMP Auditing
• Auditing Skills
• cGMP Annual Product Reviews
• Deviations and Change Control
• Fundamentals of Regulatory Affairs in Canada, Pharmahorizons
• Fundamentals of Regulatory Affairs, CanReg
• GMP for Importers/Distributors, Q&C
• GMP Overview
• HPFBI Audit Management
• ICH Stability Guidelines
• Industrial Drug Legislation (Seneca College)
• Microbiological Control and Validation
• Pharmaceutical GMP Audits and Inspections
• Preparing for FDA Pre-approval Inspections
• Product Liability Risk Management
• Skin Delivery and Dermatologicals
• SOP Writing
• Technical Writing Course, Q&C