Sterility Assurance Leader
ApplyLocation: Ocoyoacac
Time Type: Full Time
Posted On: Posted Yesterday
Job Requisition ID: R2767469
About the PositionWe 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 all stages of life. We continue to grow strongly and provide best-in-class products to protect against many illnesses such as influenza, meningitis, polio, whooping cough, bronchiolitis, and more.
We innovate vaccine manufacturing through digitization and engage in partnerships for disease prevention to sustainably maximize the impact of vaccination.
We provide employees with opportunities for growth and encourage them to develop diverse career paths within Sanofi.
Our Team:Works with all personnel in Vaccines Mexico (Antigens / FF&P) to ensure the correct implementation of sterility assurance policies on-site. Responsible for applying global documents (GOP, standards) through local site documents.
Main Responsibilities:Participate in the implementation and improvement processes of contamination control strategies at various 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, validation processes, 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/re-qualification 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 and investigations of sterility failures. Support and review excursions of viable in Grade A. Support other deviations associated with contamination control, as well as task forces created as needed.
Assist in the evaluation of new technologies related to sterility assurance.
Participate in audits/inspections/visits focused on aspects of sterility assurance.
About YouExperience: In areas of microbiology, 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 risk management.
Education: Chemical Bacteriologist Parasitologist, Microbiologist.
Languages: Advanced English (able to conduct business conversations).
Pursue Progress, Discover ExtraordinaryBetter is out there. Better medications, better outcomes, better science. But progress does not happen without people: people from different backgrounds, in different locations, doing different roles, all united by one thing: the 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.
About UsSanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by those who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Why SanofiAs an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, ensuring our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect, allowing employees to live the life they want to live.
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