Sterility Assurance Leader
Apply Location: Cuautitlán Izcalli 100% presencial Tipo de contrato: Indeterminado About the Position We are a global leader in human vaccines for over 100 years. We develop and produce a wide range of high-quality vaccines to protect people worldwide from serious diseases at every stage of life. We have continued strong growth and the best-in-class products to protect against many diseases such as influenza, meningitis, polio, whooping cough, bronchiolitis, and more. We improve people's lives by developing innovative vaccination solutions against many diseases.
We innovate in vaccine manufacturing through digitalization and engage in partnerships for disease prevention to sustainably maximize the impact of vaccination.
We provide employees with opportunities to grow and encourage them to develop diverse career paths within the Sanofi organization.
Our Team: Works with all personnel from Vaccines Mexico (Antigens / FF&P) to ensure the correct implementation of sterility assurance policies on-site. Responsible for the application of global documents (GOP, standards) through local site documents.
Main Responsibilities: Participate in the implementation and improvement process of contamination control strategies at different stages of processes according to the assigned site (Antigens / FF&P). Participate in investigations related to sterility assurance (environmental excursions, contamination issues). Review documents related to commissioning, qualification, process validation, risk assessment, and regulatory aspects related to sterility assurance. Provide training programs and implement strategies for developing competencies in sterility assurance and for the qualification/requalification of operators in the quality assurance system. Execute trend analysis for environmental monitoring and cleaning of utilities at the assigned site. Support and participate in aseptic filling simulations, as well as in sterility failure investigations. Support and review excursions of viable organisms in Grade A. Support other deviations related to contamination control, as well as task forces that may be created as needed. Assist in evaluating the introduction of new technologies related to sterility assurance. Participate in audits/inspections/visits focused on sterility assurance aspects. About You Experience: In microbiology areas, supervision of sterile areas or quality control associated with microbiology. Social Skills: Results-oriented, leadership skills, communication, negotiation, conflict resolution, teamwork. Technical Skills: Aseptic processes, critical systems, process validation and cleaning, equipment qualification, microbiology, microbiological monitoring, quality management systems, and risks. Education: Chemical Bacteriologist Parasitologist, Microbiologist. Languages: Advanced English (able to conduct business conversations). Pursue Progress, Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.
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