Assistant Manager, Quality – QMS Compliance & Audit

Zuellig Pharma; Shah Alam; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare services provider is seeking a Quality Assurance Coordinator to assist in establishing and implementing the Quality Management System. Responsibilities include maintaining the CAPA system, overseeing document control, assisting in audits, and ensuring regulatory compliance. The ideal candidate holds a degree in Quality Assurance or related field and possesses strong organizational skills, time management, and the ability to work independently. This role offers opportunities for personal and professional growth in a supportive environment.

Benefits

Inclusive work environment

Flexible work-life balance

Comprehensive Total Rewards program

Responsibilities

• Maintain and monitor the CAPA system.
• Oversee the document control function.
• Assist in external quality audits.
• Coordinate audit responses.
• Assist in self-inspections and internal audits.
• Manage change control processes.
• Maintain supplier files and Approve Supplier List.
• Execute and review Risk Management Plans.
• Report on departmental issues and accomplishments.
• Conduct and participate in meetings.
• Support cross-functional projects.
• Perform other duties as required.

Skills

Time management

Strong organizational skills

Ability to work independently

Education

Degree in Quality Assurance or related field

Job description

About Zuellig Pharma

Zuellig Pharma (ZP) is one of the largest healthcare services groups in Asia and our purpose is to make healthcare more accessible.

For over 100 years, we have been the trusted partner for healthcare companies looking to realize opportunities in Asian markets. With our deep-reaching infrastructure and sole focus on healthcare, we offer our clients unparalleled access to all healthcare channels across 13 countries in the region. Our focus is always about combining our market insight with a thorough understanding of your needs to deliver the best solution that connects you to patients. We believe delivering your products is only the first step to capturing the Asian markets. That is why we have continued to invest in developing innovative solutions that expand across Distribution, Clinical Reach, Sales & Marketing, Patient Centred Services, and Community Pharmacies.

Zuellig Pharma is the leading provider of distribution services to manufacturers in the life science industry in the Asia Pacific region. With operations in 13 countries or territories Zuellig Pharma has strong market positions, critical mass, broad geographic coverage and significant potential for continuing growth.

Purpose of the Role

To assist the Quality Manager (QM) to establish and implement the Company’s Quality Management System (QMS) encompassing the company quality policies, relevant ISOs, GSDP, GMP, GCP, GDPMD, Clients’ and Customers’ requirements, and regulatory requirements in Zuellig Pharma Malaysia (ZPMY) and Brunei (ZPBN), to ensure compliance to the requirements and quality standards.

What You’ll Do

• To maintain and monitor the CAPA system as the appointed Corrective and Preventive Actions (CAPA) Coordinator. Ensure effective implementation and reporting of CAPA responses and CAPA closure times as per regional guidelines or as per timeline required by Clients.
• To oversee the document control function ensuring documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner. Work within the company to improve the document control process through training and process improvements.
• To assist the QM in external quality audits conducted including clients, regulatory bodies, and supplier audits.
• To coordinate the audit responses from process owners and ensures that they are appropriate in these areas of coverage.
• To assist the QM in execution of self-inspections and internal audits to ensure that the Company is qualified in accordance to ISO, SOP, GSDP, GDP and GMP’s requirements as well as the Zuellig Pharma’s Code of Conduct.
• To assist QM to manage the change control process to meet amendments to local regulatory compliance and internal projects.
• To assist QM on maintenance of supplier files with required documentation and manager and maintain the Approve Supplier List ensuring follow-up requirements (audits) are met.
• To oversee Risk Management Plan (RMP) execution and continuously review the RMP for relevancy according to standard operating procedures (SOPs).
• To review and maintain key performance indexes (KPI) reporting to RQA on a timely basis for all Zuellig Pharma Malaysia (including East Malaysia branch warehouses) as well as Zuellig Pharma Brunei.
• To report to QM on departmental issues, non-conformities, and accomplishments. To ensure that there is prompt and effective communication both internally and externally to keep all interested parties informed proactively. This includes but not limited to superiors, subordinates, colleagues, principals and customers.
• To attend, participate, and conduct meetings including cross-functional meetings when needed.
• Supports and participates in cross-functional projects when assigned/appropriate.
• To perform other duties as assigned when required.

What will make you successful

Must-Have

• Degree in Quality Assurance or any related field

Advantage to Have

• Experience in supply chain environment
• Good in time management and able to meet deadlines
• Strong organizational skills, quick to learn new concepts and work independently

Why Join Zuellig Pharma

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect.