摘要
Location: Zaragoza, Spain. #LI-Onsite
We are seeking a dedicated Product Steward to join our team. In this role, you will be instrumental in enhancing the quality of our products and processes. You will collaborate with a talented team, all committed to significantly improving the lives of our patients. If you are passionate about making a meaningful impact, we would love to hear from you.
This role will work directly with the MS&T team and reports to the MS&T Site Head RLT.
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? : http://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: http://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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Innovative Medicines
ES45 (FCRS = ES045) AAA Ibérica S.L.U.
Technical Operations
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