QC Analyst

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 Requirements:

• Functional Breadth.
• 1-3years experience in Pharma/Manufacturing sector in analytical lab in.
• Collaborating across boundaries.
• a GMP environment/equivalent.

Desirable Requirements:

• Good command of English language

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

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