QC Senior Specialist - Microbiology/EM

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

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 [email protected] 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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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