QC System Expert

Job title: QC System Expert

Location: Singapore

About the job 

This role bridges quality control operations with digital transformation, serving as the local site representative for QC digital core models within global governance forums. You'll deploy and maintain LabWare LIMS and other GxP laboratory systems, ensuring data integrity and regulatory compliance. Key responsibilities include analytical method validation, equipment qualification, compendial compliance assessment, and investigation of quality events. You'll provide end-user training, manage master data access, and drive continuous improvement—all while maintaining strict cGMP and HSE standards in a regulated laboratory environment.

Main Accountabilities:

• Being representative of the site in the Business Operating Communities (BOC) related to QC digital core models, led by the global, in his/her scope and ensuring local communication.
• Executing local deployments of QC digital solutions (core model and local), in accordance with defined deployment plans and validation protocols.
• Issuing all local documentation related to QC digital solutions in scope, required to ensure their usage and maintenance in an appropriate way.
• Providing training and support of end-users on QC digital tools (in coordination with Sanofi global teams for core models).
• Maintaining and updating master data and end-user access to the QC digital tools, according to defined requirements and documentation.
• Develop and maintain routine preventive maintenance and calibration schedule of QC equipment and systems in enterprise CMMS system.
• Managing and ensure reliability of collected data within CMMS system for QC equipment maintenance activities and equipment history.
• Identify and resolve master data discrepancies within CMMS system for QC equipments.
• Support the execution of qualification and maintenance operations related to QC equipment of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Contribute to the compliance of laboratory GXP asset qualification and maintenance with applicable regulatory requirements and company quality standards.
• Informing his/her manager of any event related to digital systems in scope in a timely manner to ensure investigation and impact assessment are performed appropriately.
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately.
• Executing assigned CAPAs related to remediation plans, mitigation plans and continuous improvements.
• Support compendial compliance assessment and adherence for the QC laboratory.
• Contribute to the proper documentation, issuance, review, and approval of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
• Providing support during regulatory inspections and audits by presenting QC digital system management, validation documents and records.
• Leading initiatives for continuous improvement in QC support processes related to lab equipment management.
• Writing/reviewing protocols, user acceptance test (UAT) and reports related to QC digital system qualification activities.
• Participate in Change Control Request facilitation and management in relation to QC test methods.
• Provide technical system administrator support for QC GXP laboratory computerized systems.
• Assume role of SME for Labware LIMS and collaborate closely with global site functions to address changes.
• Ensuring laboratory instruments and facilities are kept in quality and safety status to ensure that they can be used appropriately.
• Support scheduling of routine and preventive maintenance on equipment and systems to minimize disruption to operation and maximizing equipment uptime.
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks.

Why Choose Us:

1. Impact at the Intersection of Science & Digital – Play a pivotal role in shaping how digital innovation transforms quality control, directly contributing to reliable, compliant medicines that reach patients faster.

2. Global Exposure, Local Ownership – Represent your site in global Business Operating Communities while owning end-to-end deployment, giving you both strategic visibility and hands-on impact.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!