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QA Officer Operations
3 weeks ago
**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**:
**QA Officer Operations**
**About the Role**:
Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
**Key Responsibilities**:
- 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.
- Implements 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)
**Essential Requirements**:
- Functional Breadth. QC/ QA in pharmaceutical ind./ biotech with environmental monitoring
- Collaborating across boundaries. cleanliness zones.
- Worked in Quality Control laboratory with experience on Finish product testing, handling of Analytical methods and Specifications, Method validation and transfer.
**Desirable Requirements**:
- Bachelor Degree or equivalent experience with experience in Pharmaceutical Industry/ specifically GMP background.
Division
Operations
Business Unit
Pharmaceuticals
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
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