Senior Executive Quality Assurance

DKSH Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading quality assurance provider in Kuala Lumpur is seeking a Senior Executive in Quality Assurance to oversee the Quality Management System (QMS) implementation. You will support audits, manage deviations, and provide compliance guidance. Candidates should have 3–5 years of relevant experience and a degree in Chemistry or related fields. This role emphasizes strong knowledge of regulatory compliance and document control.

Qualifications

• 3–5 years of Quality Assurance/Regulatory experience in chemicals or life sciences.
• Strong knowledge of CAPA and deviation management.
• Ability to interpret regulations and translate into procedures.

Responsibilities

• Own the country Quality Management System (QMS) and drive continuous improvement.
• Plan and support internal, client, and authority audits.
• Manage the Deviation Management process and provide QA support.

Skills

Quality Management System (QMS)

Internal/External Audits

Deviation Management

Regulatory Compliance

Document Control

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Life Sciences or related

Tools

SharePoint

Office Tools

Job description

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.