Quality Assurance Specialist

Novartis Malaysia; Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

Novartis Malaysia is seeking a Quality Assurance Specialist to strengthen quality and compliance across pharmaceutical products and medical devices. You will collaborate with internal teams, external partners, and regulatory authorities to support inspection readiness and robust data integrity initiatives.

The role involves overseeing product release, maintaining quality systems, and driving continuous improvement in quality culture across the organization.

Qualifications

• Experience in quality assurance or quality control within pharma/healthcare.
• Knowledge of GMP and GDP requirements.
• Understanding of local pharmaceutical regulations and medical-device requirements.

Responsibilities

• Maintain quality systems and procedures to ensure GMP/GDP compliance.
• Oversee product release against specifications and regulatory requirements.
• Monitor quality indicators, identify gaps, and coordinate risk mitigation actions.
• Manage inspections, deviations, recalls, complaints, and CAPAs.
• Provide quality oversight for third-party manufacturing, packaging, labelling, storage and distribution.

Skills

Quality Assurance

GMP/GDP knowledge

Regulatory affairs understanding

Stakeholder management

Documentation accuracy

Education

Life sciences degree

Job description

Summary

Location: Selangor, Malaysia

Relocation Support: This role is based in Selangor, Malaysia. Novartis is unable to offer relocation support: please only apply if accessible.

Make quality count where it matters most: protecting patients and ensuring trusted medicines reach them safely. As a Quality Assurance Specialist, you will strengthen quality and compliance across pharmaceutical products and medical devices, collaborating with internal teams, external partners, and regulatory authorities. You will help maintain robust quality systems, support inspection readiness, oversee product-release activities, and promote a strong culture of data integrity and continuous improvement across the organization.

About The Role

Deadline for applications: 28th October 2026.

Major Accountabilities

• Maintain quality systems and procedures supporting Good Manufacturing Practice and Good Distribution Practice compliance.
• Oversee product release against registered specifications and applicable regulatory requirements.
• Monitor key quality indicators, identify gaps, and coordinate timely risk-mitigation actions.
• Manage inspections, complaints, deviations, recalls, product tampering, and corrective and preventive actions.
• Provide quality oversight for third-party manufacturing, packaging, labelling, storage, and distribution activities.
• Support medical-device compliance, licensing, safety actions, complaint handling, and regulatory reporting.
• Promote data-integrity awareness and coordinate plans that strengthen a culture of responsible data management.
• Partner with supply chain, regulatory affairs, external suppliers, and regulatory authorities on quality matters.

Essential Requirements

• Degree in life sciences or a related field.
• Experience in quality assurance or quality control within the pharmaceutical or healthcare industry.
• Knowledge of Good Manufacturing Practice and Good Distribution Practice requirements.
• Understanding of local pharmaceutical regulations, quality standards, and applicable medical-device requirements.
• Fluency in written and spoken English and the local language.
• Strong communication, collaboration, and stakeholder-management skills across cross-functional and external partnerships.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis:

Helping people with disease and their families take more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Why Novartis:

Helping people with disease and their families take more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we'll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)