Summary
About the Role
Position Title : QC Specialist I - Raw Materials
Key responsibilities
• Maintain QC Raw Materials laboratory in full cGMP compliance.
• Lead raw material method validation/ verification and routine release testing
• Plan day to day operational activities in QCRM (i.e., housekeeping, release testing). Perform data entry, review and approval of RM packages for batch release
• Lead improvement projects and perform technical reviews of procedures and testing monographs for raw materials
• Lead laboratory investigations (e.g., OOS, deviation) and lead change controls for QC Raw Materials
• Lead creation and revisions of RM testing monographs
• Prepare and participate in health authority inspections and internal audits
• Other duties or projects assigned by the QC Team Leader – Raw Materials
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements :
Essential Requirement:
• University degree in Pharmacy or Chemistry or equivalent
• 5-10 years relevant experience in Pharma/Manufacturing sector in analytical lab in a GMP environment
• Experience in Raw Material Lab and Method validation
• Handling quality metrics & issues Knowledge of GMP Management of Quality Audit, Quality Change, Control Good Documentation
Why consider Novartis?
236 million lives were touched by Novartis medicines in 2022, 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!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
