QC Specialist II

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:

1. Define CAPA, perform KPI trending, and ensure all activities comply with cGxP, including data integrity review and approval of analytical data/tests (analytical release).
2. Conduct stability testing, including protocol preparation, evaluation, and report preparation.
3. Prepare stability reports, trend analyses, and evaluations.
4. Perform stability studies, develop protocols, and prepare comparative reports for supplier qualification.
5. Review and approve analytical tests (analytical release).
6. Perform microbiological testing of materials and utilities, environmental and personnel monitoring.
7. Provide expert support for site qualification and validation activities.
8. Maintain and calibrate equipment, including plan preparation.
9. Support supplier qualification processes.
10. Trend and analyze KPI/KQI data.
11. Assist in sample planning and sampling execution.
12. Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
13. Distribute marketing samples where applicable.

Experience: 3-5 years in Pharma/Manufacturing sector in an analytical lab.

Why Novartis:

Helping people with disease and their families requires more than innovative science. It takes a community of smart, passionate people like you. Collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives. Learn more about our culture.

Join our Novartis Network:

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

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

Novartis is committed to building an outstanding, inclusive work environment with diverse teams that reflect the patients and communities we serve.