Title:  Assistant Manager Quality Assurance

About the Role

The Assistant Manager, Quality Assurance supports all quality assurance-related matters for DKSH Malaysia's Healthcare Business Unit, playing a critical role in maintaining regulatory compliance, managing deviation and audit processes, and driving continuous quality improvement. This role ensures DKSH's quality standards are consistently upheld across all client and operational touchpoints.

What You Will Deliver

• Initiate, track, follow up, and close internal and external deviation reports, including conducting trend analysis to identify patterns and drive proactive quality improvements across the business
• Manage client and internal audits end-to-end, including the preparation of audit and deviation reports, and plan, schedule, and execute vendor evaluation and qualification audits
• Coordinate and conduct Quality Assurance (QA) walkthroughs, prepare walkthrough reports, and manage Corrective Action and Preventive Action (CAPA) processes by issuing tickets to process owners and maintaining accurate CAPA records
• Support the preparation and maintenance of quality-related documents including Quality Agreements, monitor change control records as backup, and actively participate in all Good Practice (GxP)-related activities and continuous improvement programs
• Prepare and submit monthly reports on regional and country quality Key Performance Indicators (KPIs), participate in annual risk assessments, maintain the risk register, and support bi-annual Management Review Meetings
• Manage product quality complaints by reporting internal and external quality issues to clients within stipulated timelines, ensure all complaints are thoroughly investigated and resolved, and provide monthly complaint logs to the Regulatory Affairs (RA) Pharmacist for Pharmacovigilance (PV) log updates and periodic client reconciliationsIdentify and report risks related to products, processes, and systems to management, while maintaining independence by avoiding conflicts of interest between quality, regulatory responsibilities, and day-to-day operations
• Supervise the discharge and handling of psychotropic drugs in full compliance with applicable regulations
• Administrative duties and coordination tasks as required

What You Bring

• Bachelor's Degree in Pharmacy; must be a registered Pharmacist
• Certification in Quality Auditor, Quality Engineer, Quality Improvement Associate, or Six Sigma is an added advantage
• Minimum five years of experience in a similar Quality Assurance role
• Minimum three years of experience in a managerial capacity
• Demonstrated knowledge of Quality Assurance tools, concepts, and methodologies, with a strong understanding of relevant regulatory requirements
• Working knowledge of Good Manufacturing Practice (GMP), International Organization for Standardization (ISO) 9000, or other quality management systems, with proven experience in GMP manufacturing environments
• Proficiency in office productivity tools including Microsoft Excel, Word, and PowerPointFluency in English, both written and spoken

Why Join DKSH

At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Quality Assurance.