Summary
Skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing.
About The Role
QC Specialist I
About The Role:
Skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing.
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
Essential Requirements:
- University degree in Pharmacy or Chemistry or equivalent
- 3-5 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 Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear 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
