Deviation & Complaint Handling Supervisor

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

Deviation & Complaint Handling Supervisor

Factory Quality Assurance

Location

Factory Lawang

Education

Job Type

Kontrak

Deadline

30/09/2026

Job Description

Job Overview

QA Deviation & Complaint Handling Supervisor will be responsible for managing deviation, product complaint, recall, and CAPA activities within the Factory Quality Assurance department. This role involves leading quality investigations, conducting root cause analysis, ensuring effective corrective and preventive actions, and providing QA oversight in manufacturing areas to maintain compliance with GMP/CPOB and applicable quality requirements.

Roles and Responsibilities

• - Lead the management of deviations and product complaints, including investigation, root cause analysis, CAPA, and effectiveness evaluation.
• - Coordinate product recall and Mock Recall activities to ensure product traceability and recall readiness.
• - Provide QA oversight in manufacturing areas to ensure compliance with GMP/CPOB requirements.
• - Conduct quality risk assessments and identify appropriate corrective, preventive, and improvement actions.
• - Prepare systematic investigation reports and communicate root causes and improvement actions to relevant stakeholders and healthcare professionals.
• - Monitor quality trends and coordinate with Production, QC, and other functions to resolve quality issues and drive continuous improvement.

Key Qualifications

• - Bachelor’s Degree in Pharmacy with Professional Pharmacist Qualification (Apoteker).
• - Minimum 2 years of relevant experience in Deviation, Product Complaint Handling, Quality Assurance, or related pharmaceutical quality functions.
• - Strong understanding of pharmaceutical quality systems and manufacturing processes.

Required Experience

• - Proven experience in deviation management and product complaint handling.
• - Experience in root cause analysis, CAPA, and quality investigation.
• - Experience in product recall and Mock Recall activities.
• - Experience in preparing systematic quality reports and communicating investigation findings and improvement actions.
• - Experience working collaboratively with cross-functional teams.

Required Skills and Competencies

• - Strong understanding of GMP/CPOB and GDP principles.
• - Knowledge of Quality Risk Management and quality investigation methodologies.
• - Strong analytical, problem-solving, and root cause analysis skills.
• - Strong report writing, data analysis, and Microsoft Excel skills.
• - Ability to clearly communicate root causes and improvement actions to healthcare professionals.
• - Strong leadership, coordination, and cross-functional communication skills.
• - Fluent in English, both spoken and written.

Additional Requirements

• - Strong attention to detail and commitment to product quality and patient safety.
• - Able to work effectively with Production, QC, and other cross-functional teams.
• - Willing to learn and adapt in a dynamic pharmaceutical manufacturing environment.