Specialist I, Quality Control Systems

(2510) Sanofi-Aventis Singapore Pte Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi is establishing a state‑of‑the‑art QC laboratory at our Singapore site and seeks a Quality Control Specialist (QC System) to ensure compliant operation of laboratory information systems and data integrity.

You will support validation, data backup, and collaboration with global Sanofi teams to implement GxP systems, contributing to a robust digital manufacturing environment for vaccines and biologics.

Qualifications

• Experience maintaining QC GxP systems and associated procedures.
• Familiarity with Laboratory Information Management Systems (LIMS) and validation.
• Knowledge of data integrity principles and regulatory expectations.
• Experience supporting regulatory audits and system upgrades.

Responsibilities

• Maintain QC GxP systems to ensure compliant operations.
• Support QC Lab Computerized System validation per Sanofi standards.
• Manage LIMS data and master data changes; control user access and security.
• Provide troubleshooting and user support for QC software and systems.
• Draft/maintain QC system SOPs and audit trails review.

Skills

QC GxP Systems

LIMS administration

Data integrity

Regulatory audits

English proficiency

Education

Bachelor’s or Master’s in Pharmaceutical Sciences / IT

Tools

Empower

Omnis

Job description

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 Modulus Facilities to our global industrial footprint. These production units 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 Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facilities will help improve people’s lives by giving them faster access to more treatments. In this context, we are seeking a highly motivated Quality Control Specialist (QC System) to join our team and play a key role in establishing and operating a state-of-the-art QC laboratory at our new Singapore site. This position offers an exciting opportunity to contribute to the successful start-up of a new facility and ensure compliance with global quality standards.

Main Responsibilities

• 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/ own 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 leading project to roll out GxP systems/ software such as Empower, Omnis
• 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.

Pursue progress, discover extraordinary 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!

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth.

Our team is guided by one purpose: we chase the miracles of science to improve people’s lives.

We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.