Quality Assurance Specialist — Pharma & Medical Devices

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

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.