QC Analyst II
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 vaccine 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 Quality Control Analyst II 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 rules of the site.
- Support the set up and routine operations of the new QC laboratory EVF-QC based in Singapore:
- Support the project execution phase through deliverables achievement and operations activities
- Write key documents relating to QC (such as SOPs and safety risk assessments)
- Support the laboratory start-up activities and participate in C&Q and validation activities
- Perform laboratory equipment maintenance, calibration and troubleshooting as and when required
- Participate in method verification for bioburden and endotoxin tests when required
- Perform aseptic sample dispensing
- Perform QC microbiological test for water, raw materials and product samples
- Perform growth promotion test and microbial identification
- Perform environmental monitoring and clean utilities sampling including WFI, clean steam and clean gases
- Train newcomers for QC lab activities and testing
- Participate and contribute to laboratory continuous improvement with regards to quality system, safety and operational efficiency
- Ensure the consistency of practices between EVF project ambition, QC Center of Excellence roadmap including new technology and Sanofi Guidelines and ensure connection with the QC Sanofi network.
- Contribute to reach the EVF quality manufacturing 4.0 ambition through a Quality plan.
- Support the Team in case of Health Authorities communication.
- Ensure Continuous Quality Improvement including lessons learned from the Group.
Education and experience
- Bachelor’s Degree or Diploma in Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with some years of experience in QC lab operations and testing.
Key technical competencies and soft skills:
- Manufacturing 4.0 mindset (such as Agile methodology)
- Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
- Knowledge of the quality systems and associated technologies.
- Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
- Experienced in routine laboratory operations and continuous improvements.
- Experienced in start-ups will be advantageous.
- 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.