Quality Assurance Specialist - Pharma & Medical Devices

Novartis Malaysia; Selangor; Presencial; MYR 60.000 - 90.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

GMP/GDP knowledge

Regulatory affairs understanding

Stakeholder management

Documentation accuracy

Educación

Life sciences degree

Descripción del empleo

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.