Quality Assurance Specialist

MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (197101000541); Selangor; On-site; MYR 60,000 - 100,000; Full time

Job summary

Novartis Corporation (Malaysia) Sdn. Bhd. is seeking a Quality Assurance Specialist in Selangor to strengthen quality and compliance across pharmaceutical products and medical devices.

You will collaborate with internal teams, external partners and regulators to ensure robust quality systems and data integrity. Responsibilities include overseeing product release, inspections, deviations and CAPAs, while supporting third-party manufacturing and regulatory reporting.

Qualifications

• Degree in life sciences or a related field.
• 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.
• Fluency in written and spoken English and the local language.
• Strong communication, collaboration, and stakeholder-management skills.

Responsibilities

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

Skills

Quality Assurance

GMP/GDP

Regulatory knowledge

Data integrity

Education

Bachelor's degree in life sciences or related field

Job description

Band Level 3 Job Description Summary #LI-Onsite 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.

Job Description 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 takes 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

Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .