Quality & Systems Supervisor

Mô tả Công việc
PART 1. QUALITY CONTROL
Quality Reporting: Support the Quality Manager in preparing and analyzing departmental performance reports, quality reports and relevant quality metrics.
Product Risk Assessment & MV Development: Identify and assess product quality risks, and establish Manufacturing Validation (MV) requirements during product development to ensure product quality and process reliability.
Production Quality Monitoring: Monitor production processes, parameters and product quality, particularly in GMP cleanroom manufacturing, to ensure compliance with customer requirements, product specifications and applicable quality standards.
Quality Investigation & CAPA: Lead or coordinate quality investigations, identify root causes, implement Corrective and Preventive Actions (CAPA), and verify their effectiveness to prevent recurrence.
QC Inspection Management: Support and monitor QC inspection activities, ensuring inspection processes are properly performed and products meet quality requirements before final release.
Customer Complaint Management: Investigate customer complaints, coordinate with relevant departments to determine root causes and implement corrective actions, and follow up on resolutions until closure.
Training & Development: Provide quality-related training and guidance to QC personnel to enhance their technical knowledge, inspection skills and awareness of quality requirements.
Quality Standards & Procedures: Develop, review and continuously improve quality control procedures, standards, specifications and work instructions to ensure consistent implementation.
Process Improvement: Identify opportunities and propose improvement initiatives to enhance product quality, process control and operational efficiency.
General Support: Perform other quality-related duties and responsibilities as assigned by the Quality Manager.
PART 2. QUALITY MANAGEMENT SYSTEMS
A. ISO 9001:2015 - Quality Management System
Maintain, monitor and continuously improve Fleming's Quality Management System (QMS) in accordance with ISO 9001:2015 requirements.
Control, review and update quality management system documentation, including policies, procedures, work instructions and forms. Coordinate with relevant departments to establish annual quality objectives, monitor performance and drive continuous improvement.
Develop the annual internal audit plan and lead internal audits. Coordinate external audits and assessments, follow up on audit findings and corrective actions, and ensure effective implementation and compliance.
B. ISO/IEC 17025 - Laboratory Quality Management System
Coordinate with the Laboratory to establish, maintain and monitor the laboratory quality management system in accordance with applicable ISO/IEC 17025 requirements.
Monitor the implementation and control of laboratory activities, including testing records, equipment calibration, testing method validation and verification, and corrective actions, as applicable.
C. GMP - ISO 22716
Implement, monitor and continuously improve GMP compliance across relevant departments in accordance with ISO 22716 requirements and applicable customer standards.
Coordinate GMP audits and assessments, monitor compliance with GMP requirements, and follow up on corrective and preventive actions to ensure effective implementation and continuous improvement.
D. Customer Audits
Lead and coordinate customer audits by working with relevant departments to conduct pre-audit self-assessments and ensure all required documents, records and facilities are properly prepared.
Act as the main contact point for customer auditors during the audit process, coordinate audit activities and provide necessary information and supporting documents.
Prepare, coordinate and follow up on CAPA plans for audit findings, ensuring timely implementation, effectiveness verification and closure of all findings.