Summary Manages Quality aspects and projects within area of responsibility.
Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
Prepares Documentation for Batch Release of commercial Pharmaceuticals.
About the Role Major accountabilities: Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
Support exception investigations.
Review and approval of production, QC, and AS and T records.
MBR review.
Support OpEx improvement projects.
Qualified Person – Executes batch release in compliance with registration.
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: On-time and GMP-compliant release of dosage forms.
No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
Successfully support continuous improvement projects.
Executes batch release in compliance with registration.
Minimum Requirements: Functional Breadth.
QC/QA in pharmaceutical industry/biotech with environmental monitoring & cleanliness zones.
Collaborating across boundaries.
Skills: Continuous Learning.
Dealing With Ambiguity.
GMP Procedures.
QA (Quality Assurance).
Quality Control (QC) Testing.
Quality Standards.
Self Awareness.
Technological Expertise.
Technological Intelligence.
Languages: English.
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: Operations Business Unit: Innovative Medicines Location: Italy Site: Milano Company / Legal Entity: IT08 (FCRS = IT008) Novartis Farma S.p.A.
Alternative Location 1: Remote, Switzerland 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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