EXECUTIVE, QUALITY ASSURANCE

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Purpose of The Role: To assist Quality Assurance Manager in overseeing the compliance with 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).

What You'll Do: (Maximum 10 points)

• Ensures assigned operation adheres to GMP/GDP/GDPMD requirements, standard operating procedures, secondary Repacking Work Instruction (RWI), batch packaging record and the quality standards set.
• Review and maintain quality assurance documents and records in compliance with document control procedures and cGMP requirements.
• Ensures only current version of RWIs are used as reference by the interested parties.
• Review batch packaging records and approve for the release of repacked products as per approved standard operating procedures.
• Action of On-Hold and Release status of repacked products and printed packaging material (PPM) related to repacking activity in accordance with the approved specifications / procedures.
• Perform investigation on reported deviation. Ensure correction and/or corrective action are complete prior to batch release.
• To execute the quality assurance procedure of each clinical trial project involving secondary repacking activity and ensures the operation adhere to its related procedures in compliance with Good Clinical Trial Practices as the appointed Quality Personnel for Clinical Trial Management (CTM).
• Attend, support and participate in meetings and projects, including cross-functional ones when assigned and is needed.
• Performs training needs analysis and on-job-training (OJT) on routine basis to evaluate competency for QA personnel who perform quality inspection and batch release.
• Document and follow up on status of product release and deal with all external parties professionally and timeously.
  
  

What Will Make You Successful: Quality-minded, detail-oriented and proactive, with the ability to apply GMP/GDP requirements in a practical operational environment. Comfortable working closely with Operations and other stakeholders, able to identify compliance risks, make sound quality decisions, and drive timely resolution of quality issues while maintaining a strong focus on patient safety and product quality.

Must-Have: (Maximum 4 points)

• Bachelor's Degree in any discipline, with relevant experience in Quality Assurance or a regulated environment.
• Minimum 2–4 years of relevant experience in Quality Assurance, GMP/GDP compliance, pharmaceutical, medical device, healthcare, or related industries.
• Good understanding of GMP, GDP and applicable regulatory requirements, with the ability to apply these requirements in daily operations..
• Strong attention to detail, documentation and problem-solving skills, with the ability to make sound quality decisions and ensure compliance.
  
  

Advantage to Have: (Maximum 8 points)

• Experience in Secondary Repackaging, redressing, relabelling or packaging operations.
• Experience in operational/on-floor QA within a GMP/GDP environment.
• Experience in batch record review, reconciliation and product release.
• Knowledge of deviation, investigation, CAPA, change control and risk assessment.
• Experience in audit preparation and supporting internal, client or regulatory audits.
• Knowledge of ALCOA/ALCOA+ and Good Documentation Practices.
• Experience with electronic quality/document management systems.
• Strong communication and stakeholder management skills, with the ability to work effectively with Operations, Warehouse, clients and other Quality teams.
  
  

What We Offer

• 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.