Batch Review Specialist

Responsibilities

• Review batch records and associated documentation to ensure compliance with regulatory requirements
• Ensure all conditional batch release activities comply with Good Manufacturing Practices (GMP)
• Approve batch records when correctly completed and meeting all quality requirements
• Identify and report deviations in batch records and escalate quality events to management
• Perform SAP activities linked to executed Batch Production Records (BPRs) accurately
• Partner with Production teams to ensure cycle times are met and implement continuous improvements
• Execute Quality System commitments including deviations, CAPAs, change controls, and audits
• Support internal and external audits and regulatory inspections by providing necessary documentation

Requirements

• Bachelor of Science or Engineering degree
• 3+ years of relevant experience in Quality Operations
• Experience within a Pharmaceutical or Biologics Manufacturing facility
• Strong knowledge of Good Manufacturing Practices (GMP)
• Ability to apply balanced judgment and risk analysis in a technical environment

Benefits

• Opportunities for career growth through promotions or lateral moves, both locally and internationally
• Comprehensive rewards package recognizing individual contributions
• Wide range of health and wellbeing benefits, including high-quality healthcare and wellness programs

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company dedicated to improving lives through innovative medicines and vaccines. We leverage a deep understanding of the immune system to protect millions of people worldwide, chasing the miracles of science to deliver life-changing treatments at scale.