Quality assurance and compliance analyst
apply locations: cuautitlan izcalli | full time | posted yesterday | end date: june 25, 2025 | job id: r2807686
position overview
we are a global leader in human vaccines for over 100 years, developing and producing high-quality vaccines to protect people worldwide at all stages of life. We continue to grow and innovate, providing solutions against diseases such as influenza, meningitis, poliomyelitis, whooping cough, bronchiolitis, and more. We focus on digitalization and partnerships to maximize the impact of vaccination and offer our employees opportunities for professional growth within sanofi.
team responsibilities
as a quality assurance and compliance analyst, you will ensure that manufacturing processes and controls are executed in compliance with good manufacturing practices (gmp) and product records, guaranteeing that intermediate and finished products meet consumer requirements through the batch release system.
main responsibilities
1. ensure compliance with quality systems, gmp, global quality directives, corporate requirements, and national standards related to vaccine manufacturing to maintain process control.
2. review and approve documentation for finished and intermediate products to ensure proper batch release.
3. conduct annual product reviews, analyze trends, and approve action plans to maintain product control.
4. investigate deviations, escalate critical events, and identify root causes with appropriate corrective actions.
5. verify monitoring plans for manufacturing services and facilities, including hvac, water, compressed air, and nitrogen systems, along with maintenance and calibration programs.
6. promote a culture aligned with policies, diversity, inclusion, and ptw (play to win) behaviors.
7. identify and control hse and gxp risks associated with activities or processes, minimizing impacts.
candidate profile
* experience in quality assurance within the pharmaceutical industry, including process inspection, area release, and document review in aseptic processes.
* strong leadership and teamwork skills.
* knowledge of quality assurance systems, risk management, validation, computer systems, and inspection criteria.
* bachelor’s degree in chemistry or related field (official degree and license required).
* intermediate english proficiency.
our commitment
we believe in progress, innovation, and diversity. Sanofi is an equal opportunity employer committed to creating an inclusive environment for all employees.
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