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:
* 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.
Minimum Qualifications:
* 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.
* 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? Learn more.
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