Summary
About the Role
Key Responsibilities:
Your responsibilities include, but are not limited to:
Maintain the oversight and knowledge for entire manufacturing process performed on site.
Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
Ensure inspection readiness for all process related aspects of assigned products.
Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
Support root cause investigation of process failures, initiate and lead product improvement projects, assess impact of technical changes, assess their technical feasibility…
Support registration activities and the creation/maintaining of the Master Batch Record.
Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification
Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
Essential Requirements:
BSc. in Pharmacy, Biotechnology, Chemical or Pharmaceutical Technology.
Strong knowledge in Statistical activities.
Thorough understanding of manufacturing processes and related process equipment.
Proficiency in Spanish & English
Desirable Requirements:
RLT, OPV and Minitab knowledge.
Ms. Sc. in Pharmaceutical Industry.
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
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
