Quality Operations Specialist II – GMP Site Support

Sanofi; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Sanofi Singapore is seeking a Specialist II, Quality Operations to provide on-the-floor quality oversight and support for GMP manufacturing at Tuas site. You will partner with operations, QA, and technical teams to ensure compliance with global quality standards and regulatory expectations.

During PPQ and routine operations you will review documentation, contribute to CAPAs, deviations, and change controls, support digital manufacturing initiatives, and drive a culture of Quality across the

Qualifications

• Bachelor’s or Master’s Degree in Sciences, engineering or related technical field is required.
• Minimum of 4 years of relevant experience in pharmaceutical manufacturing, validation, engineering or quality roles.
• Strong knowledge of cGMP, data integrity, global quality policies and QA systems.
• Experience with regulatory inspections is a plus.

Responsibilities

• Provide direct GMP Quality oversight for all GMP operations (on-the-floor quality oversight, raw materials release, deviations, change controls and CAPAs).
• Review and approve engineering and operation documents; support IOQ activities for equipment and process-related documents.
• Support digital and automation infrastructure setup (DeltaV, MES, ERP modules) and ensure quality procedures are implemented for PPQ runs.
• Lead or participate in root cause investigations and escalate significant quality issues to management.
• Contribute to QA continuous improvement initiatives during routine operations and participate in regulatory inspections.

Skills

GMP operations

Quality oversight

CAPA & change controls

Document management system

Root cause investigations

On-the-floor QA support

Cross-functional collaboration

Quality culture champion

Education

Bachelor’s or Master’s Degree in Sciences, engineering or related technical field

Tools

SAP system

MES workflows

DeltaV

Electronic Batch Records (MES)

Job description

Sanofi Singapore is seeking a Specialist II, Quality Operations to provide on-the-floor quality oversight and support for GMP manufacturing at Tuas site. You will partner with operations, QA, and technical teams to ensure compliance with global quality standards and regulatory expectations.

During PPQ and routine operations you will review documentation, contribute to CAPAs, deviations, and change controls, support digital manufacturing initiatives, and drive a culture of Quality across the