Quality Assurance Executive

Zuellig Pharma; Shah Alam; On-site; MYR 40,000 - 60,000; Full time

Job summary

A major healthcare services provider in Shah Alam, Malaysia, is looking for a Quality Assurance personnel. Key responsibilities include ensuring compliance with regulatory requirements, executing quality assurance activities for clinical trials, and managing quality quarantine operations. The ideal candidate has a degree in Quality Assurance or related field, strong organizational and time management skills, and preferably some experience in a pharmaceutical or supply chain environment. This role offers opportunities for personal growth in a supportive work culture.

Benefits

Flexible work-life balance

Inclusive work environment

Comprehensive Total Rewards program

Qualifications

• must have a degree in Quality Assurance or any related field.
• experience in supply chain or pharmaceutical environment is an advantage.
• good time management and organizational skills are necessary.

Responsibilities

• Execute quality assurance activities according to established procedures.
• Coordinate and manage quality quarantine operations.
• Monitor adherence to GMP and SOPs among staffs and third parties.
• Review and manage document control functions.

Skills

Quality Assurance

Time Management

Organizational Skills

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 ensure the end-to-end cross departmental execution of regulatory restrictions, quality control release, returns and recalls to be in compliance with the Company’s Quality Management System (QMS) encompassing the company quality policies, relevant ISO, GMP, GDP, GCP, GDPMD, clients’ and customers’ requirements; and regulatory requirements in Malaysia and Brunei, including branches

What You’ll Do :

• As the appointed Quality Assurance personnel for incoming & returns management, the incumbent executes of quality assurance activities in line with the established procedures/ approved specifications.
• To execute the quality assurance procedures of each clinical trial project and ensure the operation adhere to its related procedures in compliance with Good Clinical Practices as the appointed Quality Control Personnel for Clinical Trial Management (CTM).
• Responsible to perform final release for product disposition and execution of Usage Decision (UD) in the system.
• To coordinate, manage and monitor of quality quarantine operation process and recalls as the appointed Quality Quarantine Coordinator:

- To cascade the required information to relevant personnel cross- departments within the company to ensure timely execution as per agreed requirements and timelines.

-To ensure relevant personnel execute the prescribed transactions in accordance applicable standard operating procedures (SOP) and/or work instructions (WI) in their area of responsibility.

-To ensure there are no inadvertent releases to the market of product that is on hold/suspended.

-To monitor and track the progress of such actions to confirm all required parameters have been fulfilled and quantities that are involved are reconciled.

-Responsible contact point for clients to inform on the outcome of quality holds and recalls i.e. to release for sale, to destruct or any other actions deemed appropriate.

• To act as quality assurance representative in recall involve voluntary or mandated retrieval of products that had been distributed out from Zuellig Pharma Malaysia and Brunei, including branches, for reason/s related to quality and/or regulatory hold. Commercial recalls with no quality nor regulatory impact that are conducted by clients should be excluded from this scope.
• Monitors and enforces staffs and third parties adhere to GMP, GDP and SOPs always.
• Notify Quality Assurance Manager upon discovery of any quality incident or receipt of complaint. Assists in analysing quality issues and non-conformances and implement CAPA.
• As the Document Controller (DC), to review and manage 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 another process improvements.
• To assist Quality Assurance Manager/ Assistant Manager in external quality audits conducted including clients and regulatory body.
• To assist the Quality Assurance Manager in leading / conducting 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 attend, participate, and conduct meetings including cross-functional meetings when needed. To support and participate in cross-functional projects when assigned/appropriate.
• Ensures and maintains good housekeeping and 5S.
• 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 pr pharmaceutical 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.