Descripción de la oferta
Sandoz is a global 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. You will serve as the key technical point of contact for product-related process knowledge and provide scientific and technical support for investigations, process improvements, validations, and technical changes.Your Responsibilities Will IncludeAct 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.Lead or support root cause investigations related to process deviations, complaints, OOE, and OOS events.Define, implement, and monitor effective CAPAs to prevent recurrence of process issues.Assess technical changes, evaluate risks and benefits, and support implementation activities.Author and support process validation documentation, including protocols and reports associated with technical changes.Lead and coordinate product and process optimization initiatives in collaboration with cross-functional teams.Support registration activities and provide technical input to regulatory submissions when required.Ensure inspection readiness and compliance with GMP requirements for all process-related aspects of assigned products.Provide technical training and knowledge sharing to production personnel, process experts, and other stakeholders.Support product transfers and ensure effective knowledge transfer to receiving manufacturing sites when applicable.What You Need To Bring To The RoleBachelor'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.Strong understanding of pharmaceutical manufacturing processes, process validation, GMP requirements, and regulatory expectations.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.Effective communication and stakeholder management skills, with the ability to work across multiple functions.Fluent English; knowledge of the local language is considered an asset.Ability to work independently while collaborating within a highly regulated and cross-functional environment.Continuous improvement mindset with a focus on operational excellence, quality, and compliance.
#J-18808-Ljbffr
