Quality Control Specialist

Summary

We are seeking for someone who can support all GxP activities in the Quality department. Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions.

About the Role

Main 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 teamwork 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 inspection.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
• Customer happiness -Punctuality rate Jobs done on time, following the specified cycle time -Consistent compliance with GMP and Health, Safety and Environment guidelines and Standard Operating Procedures -No complaints with regulatory inspections

• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
• Functional Breadth.
• Collaborating across boundaries
• 2y at least as Control Quality Analyst.
• English.