Quality Management System & Compliance
• Maintain and continuously improve the Quality Management System in accordance with customer, company, and regulatory requirements.
• Ensure compliance with SOPs, Work Instructions, quality standards, and contractual obligations.
• Manage document control processes, including creation, review, approval, and periodic revision of quality documentation.
• Monitor compliance with batch traceability, product handling, FEFO/FIFO requirements, and customer-specific quality standards.
• Support implementation of new processes, products, and operational changes from a quality perspective.
Audits, CAPA & Risk Management
• Plan, coordinate, and support internal, customer, and external audits.
• Manage corrective and preventive actions (CAPA), ensuring effective root cause analysis and timely implementation of improvement measures.
• Track audit findings, quality incidents, customer complaints, and non-conformities to closure.
• Conduct risk assessments and support preventive actions to minimize operational and quality risks.
• Ensure audit readiness across all warehouse departments.
Quality Monitoring & Continuous Improvement
• Monitor quality KPIs, analyze trends, and identify improvement opportunities.
• Perform regular quality inspections, process validations, and compliance reviews.
• Lead continuous improvement initiatives focused on quality, efficiency, customer satisfaction, and operational excellence.
• Analyze quality data and operational performance to support decision-making and process optimization.
• Drive a culture of quality ownership, compliance, accountability, and continuous improvement throughout the operation.
Training & Customer Cooperation
• Coordinate quality-related training programs and ensure compliance with training requirements.
• Support onboarding and development of employees in quality standards, procedures, and customer expectations.
• Communicate with the customer regarding quality performance, audits, complaints, and improvement activities.
• Prepare quality reports, management reviews, trend analyses, and performance summaries.
• Act as the main point of contact for quality-related topics during customer meetings and reviews.