Summary
- Supports all GxP activities in the Quality department.Administers Quality Systems/ Processes inclduding documentation, metrics and monitoring of actions.Performs routine GxP Compliance/ Operational activities according to Novartis Qualtiy Standards. Contributes to 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, Qualtiy 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)
Key Performance Indicators
- Customer satisfaction, punctuality rate -Jobs done on time, following the specified cycle time -Consistent compliance with GxP and Health, Safety and Environment guidelines and Standard Operating Procedures -No complaints with regulatory inspections
Minimum Requirements
Work Experience:
Skills
- Compliance Requirements.
- Continuous Learning.
- Dealing With Ambiguity.
- Gxp.
- Industry Standards.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
Languages
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