Change Control & PQR Supervisor

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

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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.