QA Officer Operations

5 months ago


Hyderabad Telangana, India Novartis Full time

**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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