Summary
Supports all GxP activities in the Quality department. Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions and supports establishment of Quality operational processes.
- Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives
About The Role
Major Accountabilities:
- 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)
Minimum Requirement
- Familiarity with Quality Management Systems is 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.
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