Activités Industrielles
Là où les miracles
de la science
deviennent une réalité pour les patients

Position: Specialist I

• Hiring Manager: Reporting to QC Microbiology Manager

• Location: Tuas, Singapore

Mission

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 Facility will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our Modulus Facilities 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 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 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 or environmental monitoring related study.

• 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’s or Master’s 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 in start-ups will be advantageous.

• Keen to learn new technologies.

• Fluent in English speaking and writing.
  
  

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