Job Purpose

Lead the Quality Management System (QMS) and QA operations at a Pharma Factory to ensure GMP and regulatory compliance. Oversee product quality, make final batch release or rejection decisions, and drive continuous improvement.

Key Responsibilities

Quality System Management

• Maintain and improve the QMS, quality manuals, QA policies and procedures.
• Ensure GMP compliance, data integrity and consistent quality standards across all departments.

Batch Release & Product Quality

• Review batch records and approve or reject finished products for distribution.
• Oversee deviations, OOS investigations, non-conformities and change control to ensure product quality.

Audit & Regulatory Compliance

• Lead internal audits, self-inspections and external audits, including regulatory, ISO, customer and supplier audits.
• Maintain inspection readiness and ensure timely closure of audit findings.

Validation & Technical Oversight

• Oversee validation and qualification programs; review and approve protocols and reports.
• Ensure compliance in environmental monitoring, controlled areas and in-process control (IPC).

Quality Operations & Coordination

• Coordinate with Production, QC, Engineering, PPIC and Warehouse on quality compliance, storage and handling.
• Oversee supplier qualification, contract manufacturing, product complaints and recalls; support pharmacovigilance activities.

Risk Management & Continuous Improvement

• Review and approve Product Quality Reviews (PQR/APR), CAPA and quality risk assessments.
• Monitor CAPA effectiveness and quality metrics to drive continuous improvement.

People Management

• Lead and develop QA Supervisors and Staff through performance management and competency training.
• Promote quality culture and GMP awareness across the organization.

Requirements

Education

• Bachelor’s degree or higher in Pharmacy.
• Registered Pharmacist qualification is mandatory.

Experience

• 7 - 10 years of experience in the pharmaceutical industry, preferably in QA.
• Leadership and managerial experience.

Skills

• Strong knowledge of GMP, QMS and regulatory standards (FDA, EU/WHO GMP, BPOM, EMA, ISO 9001).
• Expertise in batch release, deviations, OOS, CAPA, change control, audits and validation/qualification.
• Knowledge of environmental monitoring, controlled areas, pharmacovigilance, product lifecycle and HSE.
• Knowledge of HAS with Halal training/certification (SJPH or equivalent).
• Team leadership, quality decision-making and cross-functional coordination.