Executive Quality Control

1 week ago

Mumbai, India Novartis Full time

Position Purpose:
- Highly skilled & experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing

Major Accountabilities:

- OOx/Deviation handling. -CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) - protocol preparation, evaluation, report preparation. -Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental & personnel monitoring -Provide expert Support for site qualification & validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Collaborating across boundaries Functional Breadth 2+ yrs -experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent English Laboratory Excellence Laboratory equipment Quality Control (QC) Testing Quality Control Sampling Quality decision making Knowledge of IT Applications & tools Knowledge of TQM and related industry GxP standards and processes

**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- India

**Work Location**
- Mumbai

**Company/Legal Entity**
- Sdz Pvt Ind

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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