QC Senior Specialist - Microbiology/EM

-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:

• 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.
• 3-5 years experience in Pharma/Manufacturing sector in Microbiological/EM laboratory.

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:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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

Functional Area: Quality

Job Type: Full time

Employment Type: Regular

Shift Work: No