Specialist I, Quality Control

About the job\\n\\nWe 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.\\n\\nFully 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\\n\\nIn 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.\\n\\nKey Accountabilities\\nThe mission described below, must be exercised in compliance with health, safety and environment of the site rules.\\nSupport the set up and routine operations of the new QC laboratory based in Singapore:\\n\\nSupport the project execution phase through deliverables achievement and operations activities\\n\\nWrite and review key documents relating to QC (such as URS, plans, protocols, reports, SOPs, risk assessments)\\n\\nReview and approve vendor supplied documents\\n\\nSupport the laboratory start-up activities, participate and/ or provide oversight to the C&Q and validation activities\\n\\nParticipate in method verification for bioburden and endotoxin tests or environmental monitoring related study.\\n\\nPerform aseptic sample dispensing\\n\\nPerform QC microbiological test for water, raw materials and product samples\\n\\nPerform growth promotion test and microbial identification\\n\\nPerform environmental monitoring and clean utilities sampling including WFI, clean steam and clean gases\\n\\nTrain newcomers for QC lab activities and testing\\n\\nParticipate and contribute to laboratory continuous improvement\\n\\nContribute to laboratory performance (eg, deviation/OOS rate, sample turnaround time)\\n\\nEnsure 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.\\n\\nContribute to reach the EVF quality manufacturing 4.0 ambition through a Quality plan.\\n\\nSupport the Team in case of Health Authorities communication.\\n\\nEnsure Continuous Quality Improvement in the QC laboratories.\\n\\nAbout You\\n\\nEducation and experience\\nBachelor’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.\\n\\nExperience in microbiological method verification and microbial identification in the pharmaceutical or biotechnology industry preferred.\\n\\nKey technical competencies and soft skills:\\nManufacturing 4.0 mindset (such as Agile methodology)\\n\\nKnowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.\\n\\nKnowledge of the quality systems and associated technologies.\\n\\nGood understanding of good laboratory practices, good documentation practice and data integrity requirements.\\n\\nStrong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.\\n\\nDiscipline and assertiveness in the decision-making and execution in laboratory start-up activities.\\n\\nGood communication skills to advocate QC positions with other functions, including during inspections.\\n\\nExperienced in routine laboratory operations and continuous improvements.\\n\\nExperienced in start-ups will be advantageous.\\n\\nKeen to learn new technologies.\\n\\nFluent in English speaking and writing.\\n\\nnull