QA Lead

PT Agate International; Indonesia; On-site; IDR 60,000,000 - 90,000,000; Full time

Job summary

PT Agate International is seeking a Quality Assurance leader to implement, maintain, and continuously improve the QMS across ISO 9001, ISO 17025, ISO 13485, and ISO 15189, as required by the business.

You will lead document control, audit readiness, CAPA, risk management, and internal audits; mentor the QA team; and collaborate with regulatory bodies and cross‑functional teams to ensure compliance and quality across operations.

Qualifications

• Bachelor's degree in Biology, Biomedical Science/Engineering, Pharmacy, Chemistry, Chemical/Industrial Engineering, or other related disciplines.
• Minimum 4 years of experience in Quality Assurance, Quality Management System, or laboratory operations, with at least 2-3 years in a supervisory or lead role.
• Experienced in implementing and maintaining ISO 9001 and/or ISO 17025 systems, including audit preparation and certification processes.
• Familiar with regulatory licensing and compliance requirements under government institutions such as the Ministry of Health and other related authorities.
• Good understanding of GMP, GLP, and risk-based quality management principles.
• Proficient in Google Workspace (Sheets, Docs, Slides) and/or Microsoft Office (Excel, Word, PowerPoint), and familiar with project management or quality management tools.
• Strong leadership, communication, interpersonal, and coordination skills, with the ability to work effectively in a cross-functional environment.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including ISO 9001, ISO 17025, ISO 13485, and ISO 15189.
• Ensure effective document and record control through the Document Management System (DMS).
• Oversee QA processes including risk management, change control, deviation handling, CAPA, and internal audits.
• Ensure compliance with applicable regulations, quality standards, and customer requirements; maintain audit readiness.
• Coordinate with regulatory bodies, certification agencies, auditors, and clients regarding audits and corrective actions.
• Monitor and analyze Quality KPIs, non-conformities, audit findings, and improvement initiatives.
• Collaborate with cross-functional teams to implement quality requirements across operations.
• Lead and develop the QA team through performance management and training.
• Drive continuous improvement initiatives to enhance quality systems and compliance.

Skills

Leadership

Communication

Interpersonal skills

Coordination

Audit readiness

Education

Bachelor's degree in Biology/Biomedical Science/Engineering/Pharmacy/Chemistry/Industrial Engineering

Tools

Google Workspace

Microsoft Office

Project management tools

Job description

• Lead the implementation, maintenance, and continuous improvement of the Company's Quality Management System (QMS), including ISO 9001, ISO 17025, ISO 13485, and ISO 15189 scopes as required by business needs.


• Ensure effective document and record control through the Document Management System (DMS), including SOPs, policies, forms, and quality records.


• Oversee quality assurance processes including risk management, change control, deviation handling, CAPA management, and internal audit programs to ensure compliance and process consistency.


• Ensure compliance with applicable regulations, quality standards, and customer requirements, and maintain readiness for internal and external audits.


• Coordinate with regulatory bodies, certification agencies, auditors, and clients regarding audits, inspections, and corrective action follow-ups.


• Monitor and analyze Quality KPIs, non-conformities, audit findings, and improvement initiatives to support management review and decision-making.


• Collaborate with cross-functional teams to ensure quality requirements are effectively implemented across company operations.


• Lead and develop the QA team through performance management, competency development, coaching, and training programs.


• Drive continuous improvement initiatives to enhance quality systems, operational efficiency, and compliance effectiveness.

Requirement

• Bachelor's degree in Biology, Biomedical Science/Engineering, Pharmacy, Chemistry, Chemical/Industrial Engineering, or other related disciplines.


• Minimum 4 years of experience in Quality Assurance, Quality Management System, or laboratory operations, with at least 2-3 years in a supervisory or lead role.


• Experienced in implementing and maintaining ISO 9001 and/or ISO 17025 systems, including audit preparation and certification processes.


• Familiar with regulatory licensing and compliance requirements under relevant government institutions such as the Ministry of Health and other related authorities.


• Good understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and risk-based quality management principles.


• Proficient in Google Workspace (Sheets, Docs, Slides) and/or Microsoft Office (Excel, Word, PowerPoint), and familiar with project management or quality management tools.


• Strong leadership, communication, interpersonal, and coordination skills, with the ability to work effectively in a cross-functional environment.


• Highly organized, detail-oriented, proactive, and able to manage multiple priorities effectively.


• Possess strong analytical thinking and problem-solving skills.


• Demonstrate high integrity, honesty, and accountability in daily work activities.

Job Responsibilities

Other Information