Specialist II, Quality Control (System)
Sanofi is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.
In this context, we are looking for one Specialist II, Quality Control (System) to participate in the setting up of the new QC laboratory for our new site based in Singapore.
The mission described below, must be exercised in compliance with health, safety and environment of the site rules.
- Support the set up and routine operations of the new QC laboratory EVF-QC based in Singapore:
- Responsible for the implementation and maintenance of QC GxP Systems.
- Provide oversight 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.
- Write and execute QC application software validation test scripts, and to initiate associated change control(s) and summary report(s).
- Author/ own QC Systems associated procedures such as administrative SOPs and configuration specifications.
- 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, focusing on data integrity aspects and operational processes.
- Partner with Digital team to ensure successful data backup/ restoration and archival.
- Provide oversight to QC computerized system policies and procedures to ensure they are aligned with current regulatory expectation.
- 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 minimally 10 years of experience in QC Systems.
Key technical competencies and soft skills:
- Manufacturing 4.0 mindset (such as Agile methodology)
- Good understanding of 21 CFR Part 11 and data integrity requirements
- Subject Matter Expert in GxP applications and systems
- Experience in leading project to roll out GxP systems/ software such as Empower
- Familiar with LIMS set-up and data structure
- Experience in writing and executing QC Systems test scripts
- 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.
- Keen to learn new technologies.
- Fluent in English speaking and writing.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.