Qc Senior Specialist

2 weeks ago


Tuas, Singapore Novartis Full time

**Summary**:

- Highly skilled and experienced laboratory professional who contributes by performing Microbiological In-Process and release testing, investigational support, Raw material MET/BET testing, Environmental testing (EM), support method implementation studies, etc.

**About the Role**:
**Key Responsibilities**:

- OOx/Deviation handling.
- CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of Microbiological release data / tests release, EM protocol/report preparation.
- Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and 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

**Essential Requirements**:

- 3-5years experience in Pharma/Manufacturing sector in Microbiological/EM laboratory
- Collaborating across boundaries.
- GMP environment/equivalent.

**Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

**Accessibility and accommodation**

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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


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