Qa Automation (Katalon & Selenium)

Pt Abishar Technologies Indonesia; Jawa Barat; On-site; IDR 180,000,000 - 260,000,000; Full time

Job summary

Pt Abishar Technologies Indonesia is seeking a diligent Quality Assurance Specialist to strengthen quality systems in Bekasi, West Java. The role ensures pharmaceutical products meet regulatory requirements through lifecycle management and continuous improvement.

You will develop, implement, and maintain QMS, conduct internal audits, review batch records, and drive CAPA initiatives to safeguard product quality and patient safety.

Qualifications

• Prepare and maintain the Quality Management System (QMS) per regulatory standards.
• Lead internal audits of manufacturing processes, docs, and facilities.
• Review batch records, specs, validation protocols, and quality documents.

Responsibilities

• Develop, implement, and maintain the QMS in line with cGMP and regulations.
• Conduct internal process and facility audits for compliance.
• Review and approve batch records, specs, and validation protocols.
• Investigate deviations and CAPA, and drive corrective actions.
• Support external regulatory inspections and site readiness.

Skills

Quality management

Auditing

cGMP compliance

Job description

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Quality Assurance Specialist - Pharmaceuticals

Our client is seeking a diligent and experienced Quality Assurance Specialist to enhance their quality systems in Bekasi. This role is essential for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be involved in developing, implementing, and maintaining quality assurance programs, conducting audits, and driving continuous improvement initiatives. This position offers a significant opportunity to impact product quality and patient safety within a leading pharmaceutical manufacturing facility in West Java.

About the Role

Our client is seeking a diligent and experienced Quality Assurance Specialist to enhance their quality systems in Bekasi. This role is essential for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be involved in developing, implementing, and maintaining quality assurance programs, conducting audits, and driving continuous improvement initiatives. This position offers a significant opportunity to impact product quality and patient safety within a leading pharmaceutical manufacturing facility in West Java.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure compliance.
• Review and approve batch records, specifications, validation protocols, and other quality-related documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
• Participate in external regulatory inspections and