
Qc Analyst Iv
2 weeks ago
More than 380 That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.
- This role will be responsible to ensures the release and testing of Raw Materials for production use and method validation/ verification of analytical tests to be performed on site.**Key Responsibilities**
- Maintain QC Raw Materials laboratory in full cGMP compliance, perform review and approval of RM packages for batch release
- Support in the laboratory and sampling scheduling and prioritization of activities for the Chemists. Lead the Method Validation of raw materials identification testing
- Perform technical reviews of procedures and testing monographs for raw materials. Prepare and participate in health authority inspections and internal audits
- Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release)
- Stability testing, protocol preparation, evaluation, report preparation. Reporting (Stability plan preparation, trend analysis, evaluation)
- Performance of Stability studies, protocols and comparative reports for supplier qualification
- Perform Microbiological testing of materials and utilities, environmental & personnel monitoring. Provide expert Support for site qualification & validation activities
- Maintain and calibrate equipment incl. plan preparation, support in supplier qualification, trending and analysis of KPI/KQI and support sample planning/execution
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- 5-10 years of relevant experience working experience in Laboratory environment in the Pharmaceutical industry
- Bachelor’s Degree in Data science MSc or BS in Pharmacy, Biotechnology or Chemistry
- Experience in HPLC, Raw Material Lab, Method validation
**Why consider Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
**Imagine what you could do at Novartis**
**Division**
- Novartis Technical Operations
**Business Unit**
- NTO QUALITY
**Country**
- Singapore
**Work Location**
- Singapore
**Company/Legal Entity**
- NOV SINGAPORE PHARMA MANUFG
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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