Job Description

Mission
Sanofi is preparing its future through an ambitious program named named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi 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: \xe2\x80\x9cSanofi 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 Analyst II 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.

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  Support the set up and routine operations of the new QC laboratory EVF-QC based in Singapore.

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  Support the project execution phase through deliverables achievement and operations activities.
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  Write key documents (such as SOPs and risk assessments).
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  Support the QC laboratory start-up activities, participate in the C&Q and validation activities.
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  Responsible for waste management, including liaising with waste management vendor.
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  Responsible for sample management, including sample receipt, shipment and disposal.
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  Responsible for raw material and drug substance reserve sample management program.
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  Responsible for external laboratory coordination and management.
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  Coordinate and perform raw material sampling.
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  Coordinate and perform general laboratory support activities, including procurement and inventory management.
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  Train newcomers in general QC laboratory activities.
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  Oversee QC equipment calibration and preventive maintenance program.
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  Participate and contribute to laboratory continuous improvement.
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  Maintain Sanofi standards and values for safety and quality objectives as well as contribute to laboratory performance.

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  Ensure the consistency of practices between EVF project ambition, QC Centre of Excellence roadmap including new technology and Sanofi Guidelines and ensure the connection with QC Sanofi network.
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  Contribute to reach EVF quality manufacturing 4.0 ambition through a Quality plan.
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  Ensure continuous Quality Improvement including lessons learned from the Group.

Education and experience
Diploma in Pharmaceutical Sciences, Applied Science or related life Sciences or Technology with about 5-7 years of experience in QC laboratory operations or graduates with Bachelor\xe2\x80\x99s Degree with about 3-5 years of experience.
Experience in laboratory support in the pharmaceutical or biotechnology industry preferred.
Key technical competencies and soft skills:

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  Manufacturing 4.0 mindset (such as Agile methodology)
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  Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
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  Knowledge of the quality systems and associated technologies.
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    Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
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    Experienced in routine laboratory operations and continuous improvements.
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    Experienced in start-ups will be advantageous.
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    Keen to learn new technologies.

Sanofi Behaviors and Skills
This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s 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, disability, or gender identity.
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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.