QC Specialist II

Summary

Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing

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 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 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 -Distribution of marketing samples (where applicable)

Essential Requirement:

• 3-5years experience in Pharma/Manufacturing sector in analytical lab in.
• Collaborating across boundaries.
• a GMP environment/equivalent.

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

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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

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