QA EXECUTIVE

Job Description

• Maintain & continuously improve the Quality Management System (QMS).
• Ensure compliance with cGMP, PIC/S, USFDA, ASEAN guidelines, ICH, GLP, Marketing Authorization & other regulatory requirements.
• Ensure Qualifications & Validation program (e.g. IOPQ, MV, CV, PV) meet compliance requirements.
• Serve as the document controller for the Quality Manual, SOPs, Specifications, Forms, records and quality reports.
• Generate CoA, review production & quality documents to authorize finished product batch to be Release for Sale in absence of QA Manager.
• Prepare annual Product Quality Review & management review reports.
• Manage & follow up on change controls.
• Conduct deviation investigations & follow up on CAPA implementation for proper closure.
• Handle quality issues in manufacturing operations.
• Manage customer complaints & product recalls (if any).
• Review & control ...