Associate Specialist, Quality Operations
Core
Ensure local compliance with World Courier policies and procedures, coordinate audits, and manage quality systems for pharmaceutical logistics and depot operations.
Role type
Associate Specialist, Quality Operations (Quality Assurance)
Builds
Quality-compliant pharmaceutical logistics services and depot operations
Domain
Pharmaceutical logistics / Cold chain / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
Quality Assurance, Regulatory Compliance, Audit Coordination, CAPA management, SOP review, Training delivery, Supplier/Subcontractor qualification, Risk Management, Change Control, Data entry, Recall management, Validation review, Spot checks, Security Control Systems
Preferred skills
Pharmaceutical industry experience, GxP knowledge, ISO 9001 familiarity, Logistics background
Responsibilities
Monitor and ensure company policies and procedures are followed; Coordinate internal and external audits and regulatory inspections; Participate in CAPA and complaint processes; Review and update Local SOPs and Work Instructions; Conduct training on quality topics; Manage subcontractor and supplier qualification; Support Risk Management and Change Control processes; Enter quality data into SharePoint; Ensure compliance with documentation and retention requirements; Act as first line contact for regulatory updates; Oversee calibration, maintenance, and qualification programs; Review temperature periodic reports and deviation assessments; Support recalls and mock recalls; Act as witness during product destruction; Review validation documentation; Perform spot checks on operative activities; Maintain Security Control Systems; Act as Technical Director liaison with Ministry of Health and other regulatory bodies.
Seniority
Associate, entry-level IC