Specialist I, Quality Control Systems

Job title: Specialist I, Quality Control Systems

Location: Singapore

Hiring Manager: Senior Manager, Quality Control

About the job:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.

In this context, we are looking for one Quality Control Specialist (QC Systems) to participate in the setting up of the new QC laboratory for our new site based in Singapore.

Main Responsibilities

Support the routine operations of the new QC laboratory EVF-QC based in Singapore:

• Responsible for the maintenance of QC GxP Systems.

• Provide support to the QC Laboratory Computerized System validation in compliance with Sanofi Standards and Regulatory guidance.

• Responsible for the management of Laboratory Information Management Systems (LIMS), including maintenance and change implementation of LIMS master (static) data.

• Provide user administration support to laboratory system/ software such as control and periodic review of user access.

• Manage and support routine user requests including troubleshooting and problem solving.

• Author QC Systems associated procedures such as administrative SOPs.

• Perform periodic audit trail review of Laboratory Computerized Systems.

• Partner with QC operations to conduct data integrity risk assessment, to identify potential risks and improve system control.

• Partner with Digital team to ensure successful data backup/ restoration and archival.

• Collaborate with Sanofi global team to implement or upgrade global GxP systems.

Education and experience

• Bachelor’s or Master’s Degree in Pharmaceutical Sciences, related life Sciences or IT/ Technology with minimum 4-5 years of experience in QC Systems.

Key technical competencies and soft skills:

• Good understanding of 21 CFR Part 11 and data integrity requirements

• Competent in GxP applications and systems

• Experience in implementing GxP systems/ software such as Empower

• Familiar with LIMS set-up and data structure

• Experience in troubleshooting/ problem management and configuration management.

• Experience in regulatory audits will be advantageous.

• Strong interpersonal relationships and good communication skills to establish the partnerships with key stakeholders.

• Fluent in English speaking and writing.