Job Description

Job title: QC Specialist

• Location: Singapore
• % Remote working and % of travel expected: To follow current arrangement for EVF Tuas: 40% remote (subject to change), possibility of 1 travel between 2023 to 2024.
• Job type: Permanent, Full time

Mission
Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Vaccine 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, VIA is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: \xe2\x80\x9cVIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+\xe2\x80\x9d.

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

Key Accountabilities
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:
• Support the project execution phase through deliverables achievement and operations activities
• Write and review key documents relating to QC (such as URS, plans, protocols, reports, SOPs, risk assessments)
• Review and approve vendor supplied documents
• Support the laboratory start-up activities, participate and/ or provide oversight to the C&Q and validation activities
• Participate in method verification for bioburden and endotoxin tests
• 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
• Contribute to laboratory performance (eg, deviation/OOS rate, sample turnaround time)
• Ensure the consistency of practices between EVF project ambition, QC Center of Excellence roadmap including new technology and Sanofi Guidelines and ensure the 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 in the QC laboratories.

Education and experience

• Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 3-7 years of experience in QC lab operations and testing.
• Experience in microbiological method verification and microbial identification in the pharmaceutical or biotechnology industry preferred.

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.
• Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
• Discipline and assertiveness in the decision-making and execution in laboratory start-up activities.
• Good communication skills to advocate QC positions with other functions, including during inspections.
• Experienced in routine laboratory operations and continuous improvements.
• Experienced/participated in method transfer, method validation and method verification for product and raw material testing will be advantageous.
• 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.