Quality Operations Expert II: Batch Release & Deviation

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Sanofi Aventis Singapore Pte. Ltd is seeking a Quality Operations Expert II to provide QA oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review.

The role works with Manufacturing, Quality and Regulatory colleagues to ensure products are assessed and dispositioned in line with GMP, site quality requirements and applicable standards, while supporting investigations and continuous improvement.

Qualifications

• 5+ years of QA experience in pharmaceutical industry.
• Strong knowledge of GMP and QA principles.
• Experience supporting investigations, change controls and QA systems.

Responsibilities

• Batch disposition and release for products in accordance with GMP.
• Review batch-related data and drive successful disposition decisions.
• Lead or support deviation investigations and CAPA.
• Review site change controls and Product Quality Reviews (PQR).
• Contribute to audits, inspections and continuous improvement initiatives.

Skills

QA Oversight

Deviation management

Batch release

GMP knowledge

Investigations

Quality systems

Cross-functional collaboration

Job description

Sanofi Aventis Singapore Pte. Ltd is seeking a Quality Operations Expert II to provide QA oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review.

The role works with Manufacturing, Quality and Regulatory colleagues to ensure products are assessed and dispositioned in line with GMP, site quality requirements and applicable standards, while supporting investigations and continuous improvement.