QA Executive — GMP/GDP Compliance & Batch Release

Zuellig Pharma; Shah Alam; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Inclusive environment

Diversity & inclusion

Career growth opportunities

Work-life balance

Total Rewards

Job summary

Zuellig Pharma Malaysia is seeking a Quality Assurance professional to oversee GMP/GDP compliance and support clinical trial QA activities. The role involves reviewing quality documents, ensuring current procedures, and coordinating with operations for batch release and investigations.

A strong attention to detail and regulatory knowledge are essential. The candidate will participate in cross-functional meetings, provide training, and manage documentation to ensure patient safety and product

Qualifications

• Bachelor’s Degree in any discipline is required.
• Minimum 2–4 years of relevant QA experience in a regulated environment.
• Good understanding of GMP, GDP and applicable regulatory requirements.

Responsibilities

• Ensure GMP/GDP/GDPMD compliance and adherence to SOPs and WRIs.
• Review and maintain QA documents and records per document control procedures.
• Ensure current version of RWIs is used and batch release is approved.
• Investigate deviations and ensure corrective actions before batch release.
• Execute QA procedures for clinical trial projects involving secondary repacking.
• Attend meetings and participate in cross-functional projects as needed.
• Perform training needs analysis and on-job training for QA personnel.
• Document status of product release and liaise with external parties professionally.

Skills

Quality Assurance

GMP/GDP knowledge

Documentation

Stakeholder management

Attention to detail

Education

Bachelor's degree

Tools

Electronic quality management systems

Job description

Zuellig Pharma Malaysia is seeking a Quality Assurance professional to oversee GMP/GDP compliance and support clinical trial QA activities. The role involves reviewing quality documents, ensuring current procedures, and coordinating with operations for batch release and investigations.

A strong attention to detail and regulatory knowledge are essential. The candidate will participate in cross-functional meetings, provide training, and manage documentation to ensure patient safety and product