QA Manager

Key Responsibilities

1. Incoming & In-Process Quality Control

• Establish quality standards, develop inspection plans, and oversee the incoming inspection of Raw Materials (RM) and Packaging Materials (PM) to ensure compliance with approved specifications and quality requirements.
• Monitor and control the quality of bulk products and in-process manufacturing activities to ensure that products consistently meet quality standards before release.
• Investigate and address quality issues arising during the manufacturing process and implement effective corrective actions to prevent recurrence.

2. Customer Complaint Management

• Manage customer quality complaints by conducting thorough investigations and performing Root Cause Analysis (RCA) in collaboration with relevant departments.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA) to ensure timely and effective resolution of quality issues.
• Prepare formal investigation reports, response letters, and quality summaries for customers and management.

3. OEM Quality Management

• Act as the primary quality liaison between customers, the company, and contract manufacturers (OEMs) regarding product quality issues and improvement activities.
• Plan and conduct OEM quality audits, monitor quality performance, and ensure compliance with company quality requirements.
• Evaluate OEM quality performance through regular assessments and establish improvement plans where necessary to maintain expected quality standards.

4. Continuous Quality Improvement

• Analyze quality data, KPIs, and quality metrics to identify improvement opportunities, reduce defect rates, and minimize manufacturing losses.
• Lead and drive continuous improvement initiatives to enhance product quality, process efficiency, and operational effectiveness.
• Promote the application of quality tools and methodologies to support sustainable quality improvement throughout the organization.

5. Audit & Compliance Management

• Lead and coordinate Internal and External Quality Audits in accordance with applicable standards such as GMP, ISO 22716, and ISO 9001.
• Ensure all quality-related activities comply with regulatory requirements, customer requirements, and company quality standards.
• Review, update, and maintain quality system documentation, including SOPs, Work Instructions, Specifications, and related quality records, ensuring they remain accurate and compliant.
• Monitor corrective actions arising from audit findings and ensure timely closure of all non-conformities.

6. Team Management and Personnel Development

• Supervise, assign, and monitor the performance of QA team members to ensure achievement of departmental objectives and KPIs.
• Develop employee competencies through training, coaching, mentoring, and performance management.
• Foster a strong quality culture and promote quality awareness across the organization.