Regional Environmental Monitoring Expert

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About the role

Regional Environmental Monitoring Expert • Location: Bogotá About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. 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. Your job, as Regional Qualification Specialist within our M&S Services Bogota Hub, will be acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Environmental monitoring encompasses the environmental controls of viable and non-viable particles. An EM program evaluates and trends the environmental conditions of qualified cleanroom areas and ensures these are suitable for the related activities by evaluating them against pre-determined requirements linked with the qualified cleanroom grade. Main responsibilities: • Address and discuss trends, deviations, and CAPAs during the data collection period • Conduct initial interpretation and preliminary assessment of results from different data categories • Include relevant data and graphical elements in reports for enhanced clarity • Liaise with site-specific SMEs to gain insights and incorporate their expertise • Document deviations and discuss their potential impact • Summarize findings, suggesting implications and conclusions • Write report content using CMS guidelines • Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks • Informing his/her manager of any quality or HSE event (deviations, OOx, etc.) in a timely manner to ensure investigation and impact assessment are performed appropriately • Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter • Bringing, executing and leading ideas to improve processes and “the way of work” of his/her area • Responsible for working to successfully achieve area KPIs targets • To keep an excellent working environment • To be deputy or backup for Sr. Specialist and Specialist • Support internal and external audits, regulatory inspections, and corporate assessments, ensuring full preparedness and high quality documentation • Perform comprehensive content and technical reviews to ensure accuracy, completeness, and compliance with guidelines • Verify accuracy of all data, references, and citations included in reports to ensure regulatory compliance • Ensure full compliance with GxP principles, regulatory requirements, and the company’s Quality standards throughout Environmental monitoring processes • Manage Quality Management System (QMS) records, address discrepancies, and ensure timely closure of all related documentation • Drive continuous improvement initiatives through standardization, simplification, and digitalization of Environmental Moni

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