QA Specialist, Quality Systems & Compliance

Ansell Limited; Kulim; On-site; MYR 72,000 - 108,000; Full time

Job summary

Ansell Limited in Kulim, Kedah, Malaysia, seeks an Associate Specialist, QA to maintain the plant's QMS and ensure GMP compliance. You will coordinate internal audits, support external certification audits, drive CAPA closure, and implement quality improvements across the site.

The role requires 2–3 years in Quality Assurance, knowledge of ISO 9001, and strong analytical and documentation skills, with occasional travel.

Qualifications

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or related discipline.
• Minimum 2–3 years of experience in Quality Assurance, Quality Systems, Document Control, Compliance, or related field.
• Knowledge of Quality Management Systems and ISO 9001 requirements.
• Knowledge of document control, CAPA, audit management, Management Review, and quality record requirements.

Responsibilities

• Maintain, monitor, and improve the plant QMS in line with ISO 9001 and GMP.
• Monitor quality indicators, objectives, and improvement initiatives; analyze trends.
• Coordinate document control and archival of quality records; remove obsolete documents.
• Plan and coordinate internal audits and support external audits.
• Maintain CAPA tracking and ensure timely closure and effectiveness verification.
• Support root cause investigations, risk assessments, and quality improvements.
• Coordinate and monitor QMS training and awareness activities.
• Prepare quality metrics and Management Review inputs; report progress.

Skills

Quality Management

ISO 9001

Document Control

CAPA

Audit Management

Root Cause Analysis

Statistical Analysis

MS Office (Excel, Word, PowerPoint)

Education

Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing, or related discipline

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Ansell Limited in Kulim, Kedah, Malaysia, seeks an Associate Specialist, QA to maintain the plant's QMS and ensure GMP compliance. You will coordinate internal audits, support external certification audits, drive CAPA closure, and implement quality improvements across the site.

The role requires 2–3 years in Quality Assurance, knowledge of ISO 9001, and strong analytical and documentation skills, with occasional travel.