Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
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)
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
Brazil
Site
Santo Amaro
Company / Legal Entity
BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No