Batch Release QA Lead – GMP & Quality Excellence

Sanofi Group; Singapore; Sur place; SGD 120 000 - 180 000; Plein temps

Résumé du poste

Sanofi Singapore seeks a Batch Release Lead to provide QA oversight for final drug substance disposition, batch release, deviations, change controls and Product Quality Review activities. You will collaborate with Manufacturing, Quality, Regulatory and site stakeholders to ensure GMP-compliant disposition decisions and continuous improvement.

The role requires strong experience in GMP, QA processes, and deviation investigations, with the ability to manage investigations and coordinate with

Qualifications

• At least 5 years of Quality Assurance experience in the pharmaceutical industry.
• Strong understanding of GMP and QA principles.
• Experience supporting investigations, change controls and other QA systems.
• Ability to investigate, assess and resolve quality issues or deviations.

Responsabilités

• Batch Disposition & Release: Perform final drug substance disposition for release to customers and ensure all requirements are complete before disposition.
• Deviation & Investigation Management: Act as QA reviewer for site deviations and support root cause analyses.
• Quality Systems & Compliance: Review and approve change controls; perform Product Quality Reviews and ensure regulatory alignment.
• Continuous Improvement: Identify opportunities to strengthen deviation investigations and QA processes.
• Audits & Inspections: Support internal and external audits and regulatory inspections; assist with inspection readiness.

Connaissances

Quality Assurance

GMP Knowledge

Deviation Investigations

Change Control

Description du poste

Sanofi Singapore seeks a Batch Release Lead to provide QA oversight for final drug substance disposition, batch release, deviations, change controls and Product Quality Review activities. You will collaborate with Manufacturing, Quality, Regulatory and site stakeholders to ensure GMP-compliant disposition decisions and continuous improvement.

The role requires strong experience in GMP, QA processes, and deviation investigations, with the ability to manage investigations and coordinate with