Quality Assurance & Documentation Lead

HOE Pharmaceuticals Sdn Bhd; Port Klang; On-site; MYR 45,000 - 71,000; Full time

Job summary

HOE Pharmaceuticals Sdn Bhd is seeking a QA Executive to ensure that finished products are released in a timely fashion by reviewing batch manufacturing records and keeping GMP documentation up to date.

The role includes maintaining BMR, coordinating deviations, ensuring CoA availability, and supporting QA inspections. You will also handle quality reports and cover for other QA executives as needed, under management guidance.

Responsibilities

• To ensure finished products are release 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 documentation, SOP and other 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 purpose.
• 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), Item Master etc.
• To participate actively in self-inspection programs organized by QA department.
• To cover the responsibilities of other QA Executives in their absent.
• Other responsibilities as assigned by Management

Job description

HOE Pharmaceuticals Sdn Bhd is seeking a QA Executive to ensure that finished products are released in a timely fashion by reviewing batch manufacturing records and keeping GMP documentation up to date.

The role includes maintaining BMR, coordinating deviations, ensuring CoA availability, and supporting QA inspections. You will also handle quality reports and cover for other QA executives as needed, under management guidance.