Quality Assurance Ops Lead – GMP & Digital 4.0

Sanofi Aventis Singapore Pte. Ltd

Singapore

On-site

SGD 120,000 - 180,000

Full time

4 days ago

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Job summary

Sanofi Aventis Singapore Pte. Ltd. is seeking a Quality Assurance Operational Support to partner with GMP operations, ensuring alignment with Sanofi quality standards and regulatory expectations at the Tuas/Singapore site.

The role involves on-the-floor QA oversight, deviations, CAPAs, and document control to support engineering, commissioning and qualification activities. The ideal candidate has a Bachelor’s or Master’s degree in sciences/engineering and at least 4 years of relevant experience

Qualifications

Bachelor’s or Master’s degree in sciences, engineering or related field.
Minimum 4 years of relevant pharmaceutical/biotech experience (manufacturing, validation, engineering, QA).
Strong knowledge of GMP, quality systems and regulatory expectations.

Responsibilities

Provide QA oversight for GMP operations on-the-floor and during PPQ activities.
Partner with operations to ensure compliance, reliability and efficiency.
Manage deviations, CAPAs, change controls and document management systems.
Support digital manufacturing setup including MES, ERP modules and Delta V environments.
Triages issues, conducts root-cause investigations and escalates to Quality management when needed.
Contribute to regulatory inspections and QA training to sustain a quality culture.
Lead continuous improvement initiatives and support site readiness for EVF Singapore.