QA & QMS Associate Specialist: Audit & Compliance

Ansell Global Trading Center (Malaysia) Sdn Bhd; Kulim; On-site; MYR 47,000 - 71,000; Full time

Benefits offered by this job

Competitive remuneration

Annual performance bonuses

Inclusive environment

International workplace culture

Job summary

Ansell Global Trading Center (Malaysia) Sdn Bhd in Kulim, Kedah is seeking an Assoc Specialist, QA to maintain the Plant Quality Management System (QMS) in line with ISO 9001, regulatory requirements and GMP standards. You will coordinate internal and external audits, drive CAPA closure, and support continuous quality improvement.

The role also involves training, tracking actions from Management Reviews, and reporting quality metrics to strengthen overall plant performance and supplier

Qualifications

• Bachelor’s degree in Science, Mathematics, Quality Management, Manufacturing or related field.
• 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.
• Basic knowledge of root cause analysis, risk-based thinking, AI, and statistical analysis.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Strong analytical, reporting, planning, organizational, prioritization, and problem-solving skills.
• Effective written and verbal communication with attention to detail.
• Ability to work collaboratively, demonstrate accountability, and take ownership of assigned responsibilities.
• Willingness to travel from time to time based on organizational and job requirements.

Responsibilities

• Maintain, monitor, and continually improve the plant QMS in accordance with ISO 9001 and GMP.
• Monitor QMS performance indicators, quality objectives, and improvement initiatives; analyze trends.
• Coordinate control of quality documents and records, including archiving and removal of obsolete docs.
• Plan and coordinate internal quality system and process audits; support external audits.
• Maintain audit, nonconformance, and CAPA tracking; ensure timely closure and verification.
• Support root cause investigations and corrective/preventive actions.
• Coordinate QMS training and maintain training records and compliance.
• Compile quality metrics for Management Review Meetings and report progress.
• Work with supply team to manage supplier qualification and certifications.
• Identify initiatives to strengthen QMS effectiveness and escalate major risks.

Skills

Quality Assurance

Quality Systems

Document Control

CAPA

Audit Management

Management Review

Quality Records

Root Cause Analysis

Risk-Based Thinking

Statistical Analysis

MS Office

Excel

Communication Skills

Attention to Detail

Travel Willingness

Education

Bachelor’s degree in Science/Quality Mgmt

Job description

Ansell Global Trading Center (Malaysia) Sdn Bhd in Kulim, Kedah is seeking an Assoc Specialist, QA to maintain the Plant Quality Management System (QMS) in line with ISO 9001, regulatory requirements and GMP standards. You will coordinate internal and external audits, drive CAPA closure, and support continuous quality improvement.

The role also involves training, tracking actions from Management Reviews, and reporting quality metrics to strengthen overall plant performance and supplier