Quality Assurance Specialist – GMP & Regulatory Compliance

Novartis; Selangor; Vor Ort; MYR 60.000 - 110.000; Vollzeit

Zusammenfassung

Novartis in Selangor, Malaysia is seeking a Quality Assurance Specialist to strengthen quality systems and regulatory compliance for pharmaceutical products and medical devices. You will lead inspections, oversee product release, and partner with cross-functional teams to ensure data integrity and continuous improvement.

The role focuses on maintaining quality standards, coordinating with regulators and suppliers, and promoting a culture of quality across the organization.

Qualifikationen

• Degree in life sciences or related field.
• Experience in quality assurance or quality control within pharma/healthcare.
• Knowledge of GMP and GDP requirements.
• Understanding of local regulations and medical-device requirements.
• Fluency in English and local language.
• Strong communication and stakeholder-management skills.

Aufgaben

• Maintain quality systems and GMP/GDP compliance.
• Oversee product release against specifications and regulatory requirements.
• Monitor quality indicators and coordinate risk-mitigation actions.
• Manage inspections, complaints, deviations, recalls, and CAPA.
• Provide quality oversight for third-party manufacturing and distribution.
• Support medical-device compliance, safety actions, and regulatory reporting.
• Promote data-integrity and a culture of responsible data management.
• Collaborate with supply chain, regulatory affairs, and external partners.

Kenntnisse

Quality assurance

GxP knowledge

Regulatory compliance

Communication

Stakeholder management

Ausbildung

Bachelor's degree in life sciences

Tools

LIMS

Regulatory databases

Jobbeschreibung

Novartis in Selangor, Malaysia is seeking a Quality Assurance Specialist to strengthen quality systems and regulatory compliance for pharmaceutical products and medical devices. You will lead inspections, oversee product release, and partner with cross-functional teams to ensure data integrity and continuous improvement.

The role focuses on maintaining quality standards, coordinating with regulators and suppliers, and promoting a culture of quality across the organization.