
Posted 8 hours ago
Stability Management Specialist
SanofiStability Management Specialist
Requirements
1-3 years pharmaceutical QC experience, Knowledge of cGMP, Analytical method validation, Statistical data analysis, Degree in Chemistry, Pharmacy, Biology, or related field, Intermediate-advanced English
Skills
GMPQuality Control
About the role
Responsibilities
- Own assigned stability studies for influenza vaccines in compliance with approved stability programs
- Ensure the issuance and review of all deliverables, including risk assessments, protocols, reports, data trends, deviations, and findings
- Compile stability data, including change controls and events, to provide accurate statistical analysis and trend monitoring
- Oversee timely sampling and testing execution to ensure stability reports are issued on schedule
- Manage monthly budgets, vendor quotations, invoicing, and the procurement-to-payment process
- Maintain inventories of materials, supplies, and reagents for the Quality Control area to ensure operational continuity
- Investigate and resolve quality control discrepancies, deviations, or stability trend drifts in compliance with cGMP and HSE requirements
Requirements
- 1-3 years of experience in pharmaceutical Quality Control, preferably in stability studies and budget management
- Bachelor's degree in Chemistry, Pharmacy, Biology, or a related field (e.g., Chemical Engineering, QFB)
- Solid knowledge of cGMP, analytical method validation, and stability study protocols
- Proficiency in statistical data analysis and trend monitoring
- Intermediate to advanced English language skills
- Strong analytical thinking, attention to detail, and problem-solving abilities
Preferred Qualifications
- Experience with pharmaceutical quality management systems (QualiPSO preferred)
- Experience in vendor management and procurement processes
Benefits
- Opportunities for local and international career development and lateral movement
- A comprehensive benefits package designed to recognize and empower your impact
- Exposure to cutting-edge technology, including AI and digital innovation in manufacturing
About the Company
Sanofi is a research-driven global biopharmaceutical company committed to transforming the lives of people by delivering innovative medicines and vaccines. We combine deep immunological understanding with AI-powered science to protect millions of people worldwide.
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Sanofi · Cuautitlán Izcalli
