QA Operations Specialist: Batch Release & CAPA Expert

Sanofi Group; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Sanofi is seeking a QA Operations Specialist to partner with site GMP operations and the validation team. The role involves reviewing batch records, overseeing release, leading complex investigations, and ensuring regulatory and company quality standards are met.

You will drive continuous improvement, risk management, and problem-solving across the product lifecycle. Strong QA expertise and cross-functional collaboration are required.

Qualifications

• 3–5 years of quality operations experience within the pharmaceutical industry or equivalent
• Experience in batch release, deviation and investigation handling preferred
• Strong attention to detail and ability to manage multiple quality issues effectively

Responsibilities

• Review batch records and related documentation, oversee batch release to ensure GMP compliance
• Lead highly complex root cause investigations for batches affected by deviations or lab findings
• Support CAPA tracking and timely closure, participate in internal and external audits and regulatory inspections

Education

Engineering/Science Degree or equivalent

Job description

Sanofi is seeking a QA Operations Specialist to partner with site GMP operations and the validation team. The role involves reviewing batch records, overseeing release, leading complex investigations, and ensuring regulatory and company quality standards are met.

You will drive continuous improvement, risk management, and problem-solving across the product lifecycle. Strong QA expertise and cross-functional collaboration are required.