Quality & Systems Supervisor

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.

1. EXPERIENCE & SKILLS

Relevant Experience

• At least 2 years of experience in establishing, implementing and maintaining ISO 9001, ISO/IEC 17025 and GMP management systems in a manufacturing environment, with practical hands-on experience.

GMP Experience

• Previous experience in quality management or GMP implementation at a GMP-certified manufacturing facility is highly preferred.

English Proficiency

• Good English communication skills, including the ability to prepare reports and communicate effectively in a working environment.
• Systematic Thinking & Analytical Skills:
• Strong logical, systematic and analytical thinking skills, with the ability to connect information, identify potential issues, analyze problems and determine root causes.

Problem-solving & Responsiveness

• Ability to respond promptly and effectively to quality issues, unexpected situations and operational challenges, ensuring timely resolution and follow-up.

2. EDUCATION BACKGROUND

• Bachelor's degree or above in Quality Management, Food Science, Chemistry, Chemical Engineering, Biotechnology, or other related fields.