Plan, organize, and oversee Quality Assurance activities to ensure compliance with applicable GMP standards and company quality systems Monitor and evaluate quality control processes across raw materials, production, and finished products to ensure consistency and compliance Lead and supervise QA team members in daily operations, including task delegation, performance monitoring, and development Ensure GMP compliance and manage documentation related to internal and external audits, including CAPA implementation and effectiveness monitoring Review and approve quality documents, including SOPs, reports, deviations, change controls, and validation protocols Lead investigations on product deviations, out-of-specification (OOS) results, and complaints, and ensure timely corrective and preventive actions Coordinate with cross-functional teams (Production, QC, R&D) to resolve quality-related issues and improve processes Support regulatory inspections and ensure readiness for audits by external parties (e.g., BPOM or other authorities) Drive continuous improvement initiatives related to quality systems and compliance
