10 sep
|
Sandoz
|
Palafolls
Summary Product Steward (Temporary) Sandoz is a integral market leader in generic and biosimilar medicines, committed to increasing access to high-quality healthcare for patients worldwide. As a Product Steward within the Manufacturing Science & Technology (MS&T;) organization, you will act as the technical owner of assigned products throughout their commercial lifecycle. You will maintain oversight of manufacturing process performance, ensure processes remain in a continued state of validation, and drive data-based process monitoring and continuous improvement initiatives.
In this role, you will collaborate closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Operational Excellence, and other technical functions to ensure process robustness, compliance, and sustainable product performance. Act as the technical owner and subject matter expert for assigned products throughout their commercial lifecycle. Maintain oversight of process performance and capability through statistical analysis, data trending, and ongoing process verification.
Create, maintain, and periodically review product-specific Quality Risk Analyses (QRA).
Monitor critical process parameters and quality attributes to ensure products remain in a validated state.
Review Annual Product Quality
Reviews (APQRs) and assess the state of process control. Provide technical training and knowledge sharing to production personnel, process experts, and other stakeholders. Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Technology, or a related scientific discipline. Minimum 3 years of experience in pharmaceutical manufacturing, MS&T;, process support, QA, or QC environments.
Experience in data analysis, process monitoring, statistical trending, and process capability evaluation. Knowledge of Quality Risk Management principles and investigation methodologies. Demonstrated ability to identify process improvement opportunities and drive technical projects. Strong problem-solving and analytical thinking skills with a scientific and data-driven mindset.
Fluent
English; knowledge of the local language is considered an asset. Continuous improvement mindset with a focus on operational excellence, quality, and compliance.
Assembly Language Change Control Data Analytics
General Hse Knowledge Process Control Root Cause Analysis (RCA)
📌 Product Steward (Temporary) (Palafolls)
🏢 Sandoz
📍 Palafolls