Change Control & PQR Supervisor

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

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Job Description

TASKS :

• - Review and assess Change Control proposals and their potential impact on product quality, processes, and compliance.
• - Monitor Change Control implementation from initiation through post-implementation effectiveness.
• - Coordinate annual Product Quality Review (PQR) data collection, analysis, and reporting.
• - Analyze product quality trends and identify potential risks or improvement opportunities.
• - Coordinate with relevant departments to ensure timely completion of Change Control and PQR activities.
• - Prepare and review Change Control and PQR-related documentation and reports.
• - Monitor follow-up actions and mitigation plans resulting from Change Control and PQR findings.
• - Utilize data analysis and statistical tools, including Minitab, to support quality evaluations.

RESPONSIBILITIES :

• - Lead the Change Control and PQR process to ensure compliance with GMP and applicable regulatory requirements.
• - Ensure effective 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.
• - Identify quality risks and drive appropriate mitigation and continuous improvement initiatives.
• - Collaborate with cross-functional teams to resolve quality issues and achieve organizational quality objectives.
• - Ensure quality documentation is accurate, complete, and maintained according to applicable procedures.
• - Provide leadership and guidance to the QA team in managing Change Control and PQR activities.
• - Support the organization in maintaining compliance with CPOB, PIC/S, US CFR, and other applicable cGMP requirements.

OTHER :

Education

• - Bachelor’s Degree in Pharmacy with Professional Pharmacist Qualification (Apoteker).

Experience

• - Minimum 1 year of relevant experience in Change Control, PQR, Quality Assurance, or related pharmaceutical quality functions.