Quality Assurance Officer

• Review batch manufacturing and packaging records, QC laboratory records, SOPs, logbooks, and other GMP documentation for completeness, accuracy, and data integrity.
• Monitor production and laboratory activities to ensure compliance with GMP/CPOB, approved procedures, and quality standards.
• Support deviation, non-conformance, OOS/OOT, and complaint investigations; coordinate root-cause analysis and CAPA implementation.
• Manage or support change control, document control, and periodic review of quality documents.
• Support internal audits, external audits, regulatory inspections, and implementation of corrective actions.
• Coordinate with Production, QC, Regulatory Affairs, Engineering, Warehouse, and Supply Chain to resolve quality issues and maintain compliance.

• S1 in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Chemical Engineering, Industrial Engineering, or a related field; Apoteker certification is an advantage.
• Minimum 3–5 years’ experience in Quality Assurance, Quality Management Systems, or a related GMP-regulated pharmaceutical environment.
• Strong knowledge of GMP/CPOB, SOPs, batch-record review, deviation management, CAPA, and change control.
• Experience supporting internal audits, regulatory inspections, validation activities, or supplier quality is an advantage.
• Strong attention to detail, documentation, analytical thinking, and problem-solving skills.
• Strong English and Bahasa Indonesia communication skills, both written and verbal.
• Preferred: experience with QMS/eQMS systems, SAP/ERP, data integrity, risk assessment, or annual product quality reviews.

• Compensation: Not disclosed

Strong English and Bahasa Indonesia communication skills, bo