Senior Quality Assurance Specialist - Consultant
Core
Support quality assurance and regulatory compliance for pharmaceutical, medical device, and clinical trial supply operations in the Canadian market.
Role type
Senior Quality Assurance Specialist (Consultant)
Builds
Quality systems, regulatory documentation, and compliance reports for healthcare clients.
Domain
Healthcare / Pharmaceutical / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Regulatory compliance (Health Canada GMP, Food and Drugs Act), deviation investigation, root cause analysis, CAPA management, change control, audit support, document management, KPI reporting, stakeholder liaison
Preferred skills
Regulatory Affairs or Quality Assurance certification, vendor audit experience, client audit hosting experience, operations environment experience, ASQ CQA or ISO 9001 Lead Auditor certification
Technologies
eQMS, EMS, WMS, CRM, Microsoft Office Suite
Responsibilities
Maintain establishment licences (DEL, MDEL, SL), coordinate product release approvals, review manufacturing and packaging records, manage deviation investigations and product complaints, process change control requests, support audits and recalls, develop quality policies and procedures, generate quality performance reports
Seniority
Senior, hands-on IC with team lead responsibilities
