T: 905.363.1182 x.258
TF: 1.877.877.5152 x.258
2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Sonia MacDonald is an energetic and service oriented professional over 25 years of diversified experience in Quality Control and Quality Assurance. Commended for a proactive, analytical and a team oriented approach to solving problems and executing investigations, Sonia is driven by change and continuous challenges with a talent for quickly mastering new technologies. She is recognized for her ability to engage, influence and energize individuals and teams, through enthusiasm, supportive behaviour, and excellent interpersonal skills.
Skills and Highlights, Big projects
- Development and implementation of a QMS system including processes for records management, customer complaints management, product returns and disposition, temperature monitoring of the warehouse, internal inspection process and mock recall process.
- Conducted internal self inspection audits and mock recalls.
- Led, coordinated and documented investigations of deviations, non-conformances and customer complaints using various investigation techniques and root cause analysis.
- Review of finished product and packaging specifications.
- Document review of batch records and release documents for NHP’s, DINs and Medical Devices.
- Strong ability to analyze and interpret data to identify trends.
- Consolidation of data for site license and DEL renewals.
- Hosted and led Health Canada, FDA, GMP and site inspection audits, ensuring prompt follow-up to audit findings.
- Developed GMP site training program.
- Provided training on SOPs, GMPs and compliance.
- Operated various analytical instrumentation: UV-VIS, HPLC, IR, HPLC-MS, HPLC-UV, GC-MS.
- Conducted raw material and finished product testing for drug and natural health products.
- Documented, reviewed and approved laboratory test methods.
- Managed stability program.
- Reviewed and approved laboratory test results.
- Reviewed and approved OOS, and production deviation investigations.
- Prepared, reviewed, revised and approved the following types of techinical documents that comply with GMP and cGMPs:
- Annual Product Quality Reviews for pharmaceuticals, medical devices and NHPs.
- SOPs, work instructions for QMS required processes, laboratory an production equipment.
- Quality Manual, Quality Policies and Guidelines.
- Laboratory: test methods, method transfer documentation, IQ,OQ,PQ protocols and reports for equipment.
- Stability Program protocols and reports.
- Computer validation protocols and reports.
- Supplier quality agreements.
- Inventory management systems: SAP, Red Prairie
- Laboratory Systems: LIMS
- Document, file sharing and management software systems: Sharepoint, Master Control, BOX, Documentum
- TrackWise QMS Software
- M.Sc. Analytical Chemistry, University of Waterloo, Waterloo ON
- B.Sc.Chemistry, University of Guelph, Guelph ON
Continuing Education, Career Development
- Fundamentals of Natural Health Products
- Anaytical Method Development and Validation
- OOS, Deviation Investigations
- Good Manufacturing Practices
- Quality Auditing
- Presenting Powerfully and Dale Carnegie Effective Speaking Course
- WHMIS certification
- Joint Health & Safety – Office Certification