About the role
AI summarisedQA Associate role at Novartis, responsible for maintaining GxP-compliant documentation and quality systems in the pharmaceutical industry. Supports audits, CAPA monitoring, and ensures data integrity within the Quality Management System.
BiopharmaFull-timeQuality | Development
Key Responsibilities
- Maintains applicable Standard Operating Procedures (SOPs), GxP compliant documentation and records within the Novartis Quality Management System.
- Ensures the integrity of all Quality Systems records and data, as applicable and collaboration of own team with other functions and departments.
- Ensures an adequate level of education, GxP knowledge.
- Updates and maintains relevant information in electronic systems (e.g. Change Control, Documentation, Training).
- Follow up and monitoring of e.g. CAPAs, actions, metrics, Quality plan.
- Supports Quality Audits and Health Authority inspections.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
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 would be ideal.