Senior Executive, Quality Assurance

Overview

As a Senior Executive in Quality Assurance within the Regulatory function for the Malaysian market, you will ensure that our Quality Management System (QMS) is effectively implemented and continuously improved, support audit readiness and execution, manage deviations and CAPA, and drive SOP / document control across the business. You will be a key QA contact for internal stakeholders, suppliers, and regulators, providing timely compliance support on product quality, documentation, and import / export related requirements.

Responsibilities

• Own the country Quality Management System (QMS) : maintain procedures, records and controls; drive continuous improvement.
• Plan, support and / or host internal, client and authority audits; compile reports and track CAPA to closure.
• Manage the Deviation Management process : triage, verify evidence, coordinate investigations and trend reporting.
• Maintain SOPs / WIs and document control (creation, revision, obsolescence), ensuring timely training and adherence.
• Provide QA support to business operations (e.g., product release documentation, customer questionnaires, vendor assessments).
• Coordinate with Regulatory Affairs and SHE on compliance topics (e.g., SDS / GHS, dangerous goods, poison license) as applicable.
• Prepare and submit required quality / compliance reports to relevant authorities in accordance with local regulations.
• Monitor regulatory and standard updates (e.g., ISO 9001, GDP) and translate into pragmatic QA actions.

Qualifications

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