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.
