Sterility Assurance Specialist

Responsibilities

• Ensure environmental monitoring (EM) operations fulfill GMP requirements and prepare relevant specifications and analytical test methods.
• Lead projects related to continuous improvement, validation, and investigations in EM and sterility assurance.
• Support the implementation of contamination control strategies (CCS) to prevent contamination in sterile product manufacturing.
• Troubleshoot microbial contamination issues in equipment, utilities, materials, products, and production-related validation.
• Develop or assist in developing microbial and EM assessment SOPs to support routine operations.
• Analyze trends in analytical results and ensure proper investigation of any exceeding limits.
• Perform GAP analysis between global requirements and local authority standards, implementing necessary CAPA actions.
• Participate in audits as a Sterility Assurance Subject Matter Expert (SME).
• Support clean zone re-construction, process optimization, and technical training deployment regarding contamination control.

Requirements

• Minimum of 3 years of QA/SA experience specifically for sterile products.
• Strong knowledge of both Chinese and international GMP requirements.
• B.S. degree or higher in Chemistry, Pharmacy, Biology, or Microbiology (Microbiology preferred).
• Proven problem-solving skills and a proactive approach to investigations.
• Good English communication skills (listening, writing, and speaking).
• Experience in microbiology analytical methodologies and management is preferred.

About the Company

Sanofi is a global healthcare leader dedicated to transforming the lives of patients through science. Our Manufacturing & Supply division produces and delivers over 4 billion units of medicines and vaccines every year. We combine state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation to ensure treatments reach the people who need them most, safely and sustainably.