QA Deviation & Complaint Lead — GMP/CAPA Expert

Otsuka; Kota Malang ꦠꦸꦛꦩꦭꦁ; On-site; IDR 120,000,000 - 180,000,000; Part time

Job summary

Otsuka eagerly seeks a Deviation & Complaint Handling Supervisor in our Factory Quality Assurance team at the Lawang facility. You will manage deviations, product complaints, recalls, and CAPA activities, leading root cause analyses and ensuring CAPA effectiveness while upholding GMP/CPOB standards across manufacturing operations.

You will coordinate recalls, provide QA oversight in production areas, and engage with cross-functional teams to drive risk-based improvements, reporting findings

Qualifications

• Bachelor’s degree in Pharmacy with professional pharmacist qualification (Apoteker).
• Experience in deviation management, product complaints, QA, or related pharmaceutical quality functions.

Responsibilities

• Lead deviation and product complaint investigations, CAPA, and effectiveness reviews.
• Coordinate product recall and Mock Recall activities for traceability and readiness.
• Provide QA oversight in manufacturing areas to ensure GMP/CPOB compliance.
• Perform quality risk assessments and define corrective, preventive, and improvement actions.
• Prepare investigation reports and communicate findings and actions to stakeholders and healthcare professionals.
• Monitor quality trends and collaborate with Production, QC, and other functions to drive improvements.

Skills

GMP/CPOB understanding

Quality risk management

Root cause analysis

Data analysis

English communication

Education

Bachelor’s Degree in Pharmacy with Pharmacist Qualification (Apoteker)

Tools

Microsoft Excel

Job description

Otsuka eagerly seeks a Deviation & Complaint Handling Supervisor in our Factory Quality Assurance team at the Lawang facility. You will manage deviations, product complaints, recalls, and CAPA activities, leading root cause analyses and ensuring CAPA effectiveness while upholding GMP/CPOB standards across manufacturing operations.

You will coordinate recalls, provide QA oversight in production areas, and engage with cross-functional teams to drive risk-based improvements, reporting findings