GMP Quality Lead - Change Control & PQR

Otsuka; Indonesia; Hybrid; IDR 89,280,000 - 200,880,000; Full time

Job summary

Otsuka Indonesia is seeking a Quality Assurance professional to lead Change Control and PQR processes, ensuring GMP compliance and thorough documentation.

You will coordinate annual PQR activities, monitor change implementation, analyze quality trends with tools like Minitab, and collaborate across functions to drive continuous improvement.

Bachelor’s in Pharmacy (Apoteker) with at least 1 year in QA/Change Control is required; improve product quality and ensure regulatory readiness.

Qualifications

• Bachelor’s Degree in Pharmacy with Professional Pharmacist Qualification (Apoteker).
• Minimum 1 year of relevant experience in Change Control, PQR, Quality Assurance, or related pharmaceutical quality functions.

Responsibilities

• Lead the Change Control and PQR process to ensure GMP compliance and proper governance.
• Ensure assessment, implementation, monitoring, and closure of quality-related changes.
• Lead the annual Product Quality Review (PQR) process and ensure meaningful evaluation of product quality trends.
• Coordinate with cross-functional teams to complete Change Control and PQR activities on time.
• Prepare and review Change Control and PQR documentation and reports.
• Monitor follow-up actions and mitigation plans from Change Control and PQR findings.

Job description

Otsuka Indonesia is seeking a Quality Assurance professional to lead Change Control and PQR processes, ensuring GMP compliance and thorough documentation.

You will coordinate annual PQR activities, monitor change implementation, analyze quality trends with tools like Minitab, and collaborate across functions to drive continuous improvement.

Bachelor’s in Pharmacy (Apoteker) with at least 1 year in QA/Change Control is required; improve product quality and ensure regulatory readiness.