Supports all GxP activities in the Quality department. Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions. Supports establishment of Quality operational processes. Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives.
About the RoleMajor 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 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).Key performance indicators: Customer satisfaction.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.Functional Breadth.QC/ QA in pharmaceutical ind./ biotech with environmental monitoring.Skills: Dealing With Ambiguity.GMP Procedures.QA (Quality Assurance).Quality Control (QC) Testing.Quality Standards.Technological Expertise.Languages: Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Division: Oncology
Business Unit: Innovative Medicines
Location: Italy
Site: Ivrea
Company / Legal Entity: IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area: Quality
Job Type: Full time
Employment Type: Temporary (Fixed Term)
Shift Work: No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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