Quality Operations Lead - Batch Release & QA

Sanofi; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Sanofi in Singapore is seeking a Quality Operations Expert II to oversee final drug substance disposition, batch release and deviation management in a GMP environment. You will collaborate with Manufacturing, Quality, Regulatory and site stakeholders to ensure compliant lot disposition and robust quality processes.

The role requires strong QA expertise, experience with change controls, investigations and continuous improvement, and the ability to operate in a fast-changing setting while

Qualifications

• At least 5 years of Quality Assurance experience within the pharmaceutical industry, with a strong focus on deviation management and batch release/disposition processes.
• Strong knowledge and practical understanding of GMP and Quality Assurance principles.
• Experience supporting quality investigations, change controls and other pharmaceutical Quality systems.
• Excellent analytical and problem-solving skills.

Responsibilities

• Batch Disposition & Release: final drug substance disposition for release to secondary customers.
• Review batch-related quality information and ensure all requirements are satisfactorily completed prior to disposition.
• Investigate and resolve issues or deviations impacting batch release.
• Ensure all batch release and disposition activities are performed in compliance with GMP and applicable quality requirements.
• Participate in Quality Alert/Product Alert meetings, ensuring investigations and actions support lot disposition decisions.
• Deviation & Investigation Management: QA reviewer for site deviations; lead root cause analysis investigations and implement corrective/preventive actions.
• Review investigation outcomes and assess potential impact to product quality and batch disposition.
• Serve as the operational quality contact for complaint investigations requiring site support.
• Quality Systems & Compliance: review, assess and approve site change controls and perform Product Quality Reviews (PQR).
• Collaborate with Regulatory Support Officer to ensure compliance with local and international regulatory requirements.
• Continuous Improvement: identify and implement improvements to deviation investigation processes and quality systems.
• Audits & Inspections: participate in internal and external audits and regulatory inspections; support inspection readiness and follow-up of observations.

Skills

Quality Assurance

GMP

Deviation management

Root cause analysis

Batch release

Cross-functional collaboration

Job description

Sanofi in Singapore is seeking a Quality Operations Expert II to oversee final drug substance disposition, batch release and deviation management in a GMP environment. You will collaborate with Manufacturing, Quality, Regulatory and site stakeholders to ensure compliant lot disposition and robust quality processes.

The role requires strong QA expertise, experience with change controls, investigations and continuous improvement, and the ability to operate in a fast-changing setting while