Kerja Sepenuh Masa QA EXECUTIVE, Gaji tinggi MYR 3,500 di Bio Tree Pharmaceutical (Int'l) Melaka - Maukerja

• 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.

Pay: RM2,500.00 - RM3,500.00 per month

Benefits:

• Free parking
• Maternity leave

Work Location: In person