Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Prepare Documentation for Batch Release of commercial Pharmaceuticals
About the Role
Major accountabilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. 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)
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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:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- Collaborating across boundaries.
- cleanliness zones.
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.
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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