To maintain, control and distribute all quality-related documentation (SOPs, forms, BMR, BPR, records) in compliance with GMP and GDP principles, including revision updates.
To execute for the preparation, revise, issuance, and control Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in compliance with GMP requirements.
To coordinate compliance-related training, including GMP refresher and SOP training.
To maintain training records and monitor training effectiveness.
To maintain the Training Need Analysis and Internal Training Plan for all department.
To manage change control process to ensure all changes are evaluated, approved, and implemented according to GMP.
To oversee investigation and documentation of deviations, incidents, and non-conformances.
To manage CAPA system, ensuring timely closure and effectiveness checks.
To execute and investigate customer complaints, coordinate with production/QA/QC for root cause analysis and corrective actions.
To execute and manage Out of Specification (OOS) and Out-of-Trend (OOT) investigations in coordination with QC/Production.
To coordinate and manage product recall activities, including documentation, reporting, and regulatory communication when required.
To coordinate, support, and participate in internal, external, and regulatory audits, including audit scheduling, preparation, facilitation, and follow-up actions.