Quality Operations Specialist II - GMP & Digital 4.0

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi Aventis Singapore Pte. Ltd.

is seeking a Specialist II, Quality Operations to provide Quality oversight on-the-floor and collaborate with GMP operations to ensure the Tuas Singapore site meets Sanofi global quality standards and regulatory expectations. The role requires 4+ years in pharma/biotech quality or related manufacturing fields, with strong knowledge of cGMP, QMS and digital manufacturing concepts.

Qualifications

• Bachelor’s or Master’s Degree in Sciences or related technical field.
• Minimum 4 years of experience in manufacturing, validation, engineering, or quality in pharma/biotech.
• Experience with vaccine/biologics preferred.

Responsibilities

• Provide Quality oversight on-the-floor to ensure compliance and reliability.
• Collaborate with GMP operations, manufacturing, facilities, QC and technical units.
• Lead QA-related investigations, CAPAs and deviations.
• Support PPQ and engineering runs and commissioning activities.
• Contribute to Quality 4.0 initiatives and regulatory inspections.

Skills

Quality Operations

GxP Compliance

cGMP Knowledge

Analytical Thinking

Education

Bachelor’s or Master’s Degree in Sciences/Engineering

Tools

SAP

MES

QMS

Electronic Batch Records

Job description

Sanofi Aventis Singapore Pte. Ltd.

is seeking a Specialist II, Quality Operations to provide Quality oversight on-the-floor and collaborate with GMP operations to ensure the Tuas Singapore site meets Sanofi global quality standards and regulatory expectations. The role requires 4+ years in pharma/biotech quality or related manufacturing fields, with strong knowledge of cGMP, QMS and digital manufacturing concepts.