Product Steward (Temporary)

Sandoz Iberia; Palafolls; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Sandoz Iberia is seeking a Product Steward within the Manufacturing Science & Technology organization. You will act as the technical owner of assigned products throughout their commercial lifecycle, oversee process performance, and drive data-based monitoring to keep processes in a validated, compliant state.

This role collaborates with Production, QA, QC, Regulatory Affairs and other technical functions to support investigations, process improvements, validations, and regulatory changes,

Formación

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Technology, or a related science.
• Minimum 3 years of experience in pharmaceutical manufacturing, MS&T, process support, QA, or QC.
• Strong knowledge of GMP, regulatory expectations, and process validation.
• Experience in data analysis, statistics, and process capability evaluation.
• Excellent problem-solving and communication across functions.

Responsabilidades

• Act as technical owner and SME for assigned products throughout lifecycle.
• Monitor process performance and maintain validated state via data trends.
• Lead or support CAPAs and root cause investigations for deviations.
• Review APQRs and assess state of process control.
• Collaborate with QA, regulatory, and production for improvements.
• Support process validation documentation and tech transfers as needed.

Conocimientos

Quality Risk Management

Statistical analysis

Data analysis

Process validation

GMP compliance

Root cause investigations

Cross-functional collaboration

Process monitoring

Educación

Bachelor's Degree in Pharmacy/Chemistry/Chemical Engineering/Pharmaceutical Technology

Descripción del empleo

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 Include

• 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.
• 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 Role

• 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.
• 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.