Senior Specialist Quality Assurance
Core
Ensure quality and compliance for importation, distribution, and wholesaling of pharmaceutical products across the EEMERA region.
Role type
Senior Specialist Quality Assurance (Pharmaceuticals)
Builds
Quality services and regulatory compliance for pharmaceutical supply chain
Domain
Healthcare / Pharmaceuticals
Required skills
Pharmaceutical Quality system expertise, Supply chain management, Regulatory compliance, Corrective and Preventive Actions (CAPA), Deviation management, Quality Risk Management, Audit execution, Recall management
Preferred skills
Multi-divisional management experience, Stakeholder communication
Technologies
OMS Quality Manual, PQC systems, PQR systems
Responsibilities
Ensure adherence to regional laws and regulations for product importation, distribution, and wholesaling; Provide feedback on the OMS Quality Manual; Collaborate with Regulatory Affairs and Customer Service to resolve quality issues; Manage PQCs and quality defects for the defined market; Review and assess Corrective and Preventive Actions and Change requests; Track, follow-up, and report on deviations; Support Quality Risk Management for PQRs and Technical Quality Agreements; Assist in internal and vendor audits; Participate in Regulatory Inspections.
Seniority
Senior, hands-on IC
