QC Systems Lead – Digital Lab & GxP (Singapore)

Sanofi Aventis Singapore Pte. Ltd; Singapore; Presencial; SGD 70.000 - 95.000; Tempo integral

Resumo da vaga

Sanofi Singapore Pte. Ltd. seeks a highly motivated Quality Control Specialist (QC System) to establish and operate a state‑of‑the‑art QC laboratory at our new Singapore site.

You will contribute to the start‑up, ensure compliance with global quality standards, and support the rollout of GxP systems. The role requires a degree in Pharmaceutical Sciences or related field with 4–5 years’ QC systems experience, strong data integrity knowledge, and fluency in English.

Qualificações

• Bachelor’s or Master’s Degree in Pharmaceutical Sciences or related Life Sciences, or IT/ Technology with minimum 4–5 years in QC Systems.
• 4–5 years of experience in QC Systems.
• Experience with GxP systems and data integrity.
• Experience in regulatory audits is advantageous.
• English fluent in speaking and writing.

Responsabilidades

• Support the routine operations of the new QC laboratory EVF-QC based in Singapore.
• Maintain QC GxP Systems.
• Support QC Laboratory Computerized System validation per Sanofi standards and regulatory guidance.
• Manage Laboratory Information Management Systems (LIMS), including maintenance and changes to LIMS master data.
• Provide user administration support to laboratory systems/software; manage user access reviews.
• Handle routine user requests including troubleshooting.
• Author or own QC systems SOPs.
• Perform periodic audit trail reviews of Laboratory Computerized Systems.
• Partner with QC operations to assess data integrity risks and improve controls.
• Collaborate with Digital team to ensure data backup/restoration and archival.
• Work with Sanofi global teams to implement or upgrade global GxP systems.

Conhecimentos

GxP systems

Part 11

Data integrity

LIMS

Troubleshooting

Regulatory audits

Stakeholder comms

English fluency

Formação

Pharmaceutical Sciences degree

Ferramentas

Empower

Omnis

LIMS

Descrição da vaga

Sanofi Singapore Pte. Ltd. seeks a highly motivated Quality Control Specialist (QC System) to establish and operate a state‑of‑the‑art QC laboratory at our new Singapore site.

You will contribute to the start‑up, ensure compliance with global quality standards, and support the rollout of GxP systems. The role requires a degree in Pharmaceutical Sciences or related field with 4–5 years’ QC systems experience, strong data integrity knowledge, and fluency in English.