Job Description

Location:
Kuala Lumpur, MY, MY
Global Business Unit: PM
Job Function: Regulatory Services
Requisition Number: 217728
Description:

Job Summary

As a Senior Executive in Quality Assurance within the Regulatory function for the Malaysia 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.

Job 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.

Job Requirements

Bachelor's degree in Chemistry, Chemical Engineering, Life Sciences or a related discipline. 3-5 years of Quality Assurance/Regulatory experience in chemicals, life sciences or related industries. Malaysia market exposure is an advantage. Strong knowledge of QMS, internal/external audits, CAPA and deviation management. Working knowledge of Safety Data Sheets (SDS), GHS and dangerous goods requirements; familiarity with GDP and ISO 9001. Solid SOP/document control and data accuracy discipline; proficient with SharePoint/Office tools. Ability to interpret regulations and translate into clear procedures and training.
Requisition Number: 217728
Job Function: Regulatory Services