Contract QA Lead - Product Release & Compliance

HOE Pharmaceuticals Sdn Bhd; Port Klang; On-site; MYR 48,000 - 60,000; Full time

Job summary

HOE Pharmaceuticals Sdn Bhd is seeking a QA Coordinator to ensure product release in line with production planning and QA requirements. You will review batch manufacturing records, maintain GMP documentation, and secure COA availability for shipments and registrations.

You will also coordinate rework/reject activities, participate in self-inspections, and cover QA Coordinator duties in their absence, reporting to Management.

Responsibilities

• To act as an authorized person for product release and ensure that the products are released in timely manner in accordance with production planning & delivery schedule.
• To ensure finished products are released in timely fashion through reviewing and checking completion batch manufacturing record.
• To ensure that the manufacturing document e.g. BMR for products are maintained and updated with the latest requirement / amendment by monitoring/initiating the change control and deviation.
• To ensure all QA documentation and GMP related records are in order and update manner
• To ensure Certificate of Analysis (CoA) for each batch produced is available for shipment and registration purposes.
• To coordinate and monitor Rework, Redress and any Rejection activity.
• To ensure appropriate handling and filing of Quality related reports e.g. Inventory Request (IR), Material Master etc.
• To participate actively in self-inspection programs organized by QA department.
• To cover the responsibilities of another QA Coordinator in their absence.
• Other responsibilities as assigned by Management

Job description

HOE Pharmaceuticals Sdn Bhd is seeking a QA Coordinator to ensure product release in line with production planning and QA requirements. You will review batch manufacturing records, maintain GMP documentation, and secure COA availability for shipments and registrations.

You will also coordinate rework/reject activities, participate in self-inspections, and cover QA Coordinator duties in their absence, reporting to Management.