About the role
AI summarisedQA Associate role at Novartis in Mapletree Business City (MBC), Singapore.
BiopharmaOnsiteQuality | Development
Key Responsibilities
- Maintain applicable Standard Operating Procedures (SOPs), GxP compliant documentation, and records within the Novartis Quality Management System.
- Ensure the integrity of all Quality Systems records and data through collaboration with other functions and departments.
- Update and maintain relevant information in electronic systems (e.g., Change Control, Documentation, Training).
- Follow up and monitor CAPAs, actions, metrics, and Quality plans.
- Support Quality Audits and Health Authority inspections.
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
Requirements
- Familiarity with Quality Management Systems in the pharmaceutical industry.
- Familiarity/experience within a Good Manufacturing Practices (GMP) atmosphere.
- 1-2 years' experience in GMP documentation review, approval, and/or release (ideal).