QA Change Control & PQR Lead (GMP)

Otsuka; Lawang; On-site; IDR 180,000,000 - 280,000,000; Full time

Job summary

Otsuka is seeking a QA professional to lead Change Control and the Product Quality Review (PQR) processes, ensuring GMP compliance and robust quality management. You will coordinate data collection, analysis, and reporting, driving risk mitigation and continuous improvement across cross-functional teams.

Your role emphasizes monitoring changes, ensuring timely closure, and maintaining quality documentation while leveraging Minitab for data-driven evaluations.

Qualifications

• Qualification in pharmacy with regulatory quality experience.
• Experience in Change Control, PQR and GMP.
• Proficiency in data analysis and quality systems.

Responsibilities

• Lead Change Control and PQR processes to ensure GMP compliance.
• Assess and monitor quality-related changes from initiation to closure.
• Coordinate annual Product Quality Review (PQR) data collection and reporting.
• Analyze quality trends and identify risks and improvements.
• Collaborate with cross-functional teams to resolve quality issues.
• Ensure documentation accuracy and maintenance per procedures.

Skills

Change Control

PQR

Quality Assurance

GMP compliance

Minitab

Education

Bachelor's Degree in Pharmacy

Apoteker (Professional Pharmacist)

Tools

Minitab

Job description

Otsuka is seeking a QA professional to lead Change Control and the Product Quality Review (PQR) processes, ensuring GMP compliance and robust quality management. You will coordinate data collection, analysis, and reporting, driving risk mitigation and continuous improvement across cross-functional teams.

Your role emphasizes monitoring changes, ensuring timely closure, and maintaining quality documentation while leveraging Minitab for data-driven evaluations.