Quality Coordinator at EHA Clinics

Duties and Responsibilities   
Purpose:

• Coordinate and optimize the integrated Quality Management System (QMS) across warehouse and supply chain operations to ensure compliance with ISO 9001 and pharmaceutical regulatory standards.
• Lead cross-functional quality oversight activities relating to GDP, GSP, PCN compliance, pharmacovigilance obligations, cold chain management, inventory traceability, and controlled medicines handling.
• Coordinate enterprise-level document control processes, including SOP lifecycle management, quality manuals, CAPA documentation, deviation records, audit documentation, and training compliance systems.
• Manage complex quality investigations involving deviations, non-conformities, temperature excursions, customer complaints, inventory discrepancies, and operational failures while ensuring effective root cause analysis and CAPA implementation.
• Coordinate pharmacovigilance processes, including adverse drug reaction escalation, product quality complaint investigations, and regulatory reporting requirements in line with applicable standards.
• Conduct quality risk assessments and implement preventive controls to minimize operational, financial, compliance, and reputational risks.
• Support regulatory licensing activities, PCN inspections, ISO certification processes, partner audits, and external compliance assessments.
• Analyze quality trends, compliance data, audit findings, and operational performance metrics to identify systemic gaps and implement sustainable process improvements.
• Drive continuous improvement initiatives that strengthen operational efficiency, compliance maturity, service quality, and organizational performance.

Engagement:

• Align warehouse, procurement, logistics, pharmacy, and management teams toward organizational quality objectives, compliance priorities, and operational standards.
• Serve as the primary coordination point for internal audits, mock audits, external audits, certification activities, and regulatory inspections while ensuring continuous audit readiness.
• Collaborate with cross-functional stakeholders to strengthen integrated operational controls, compliance systems, and service delivery processes.
• Lead organisation-wide quality and compliance training initiatives on ISO 9001, GDP, GSP, pharmacovigilance, CAPA systems, PCN requirements, and SOP compliance.
• Engage professionally with regulatory authorities, auditors, certification bodies, vendors, and partners on quality, compliance, and regulatory matters.
• Support strategic decision-making through quality reporting, KPI dashboards, risk analysis, compliance trend monitoring, and operational quality insights.

Delivery:

• Sustain high-quality service delivery through effective coordination of quality systems, operational controls, and regulatory compliance activities.
• Ensure timely closure of CAPAs, deviations, audit findings, pharmacovigilance actions, and compliance action plans within defined timelines.
• Maintain high standards of documentation integrity, data accuracy, process traceability, and operational compliance across warehouse and supply chain functions.
• Monitor quality KPIs and support management review processes with actionable recommendations for operational and quality improvement.
• Drive a culture of accountability, continuous improvement, quality excellence, and regulatory compliance across operational teams.
• Support successful certification, recertification, and maintenance of ISO 9001 and other applicable quality and regulatory standards.
• Strengthen quality systems and integrated operational processes to support organizational growth, scalability, operational resilience, and customer satisfaction.

Targeted Specialized Knowledge

• Bachelor of Pharmacy (B.Pharm) degree required.
• Valid PCN practising licence required.
• 1–2 years’ progressive experience in pharmaceutical quality assurance, pharmaceutical warehouse operations, pharmacovigilance, regulatory compliance, or supply chain quality management.
• Demonstrated experience supporting ISO 9001 implementation, QMS coordination, audit management, regulatory inspections, CAPA management, and quality compliance monitoring.
• Strong knowledge of GDP, GSP, ISO 9001 standards, pharmacovigilance requirements, PCN regulations, quality risk management systems, cold chain management, and pharmaceutical quality standards.
• Experience coordinating quality improvement initiatives, regulatory documentation systems, and compliance programmes within regulated healthcare or pharmaceutical environments.
• Relevant quality certification, such as ISO 9001 Internal Auditor, or related quality management certification, will be an added advantage.
• Proficiency in Microsoft Office Suite, ERP systems, inventory management systems, quality documentation systems, and data analysis/reporting tools.
• Strong analytical, leadership, stakeholder management, organisational, project coordination, and problem-solving skills with exceptional attention to detail.

Benefits:

• Health Coverage Benefit 
• Performance Bonus
• 13th Month
• Annual Skills Assessment.