Especilista de Validación en Aseguramiento de Calidad

Job Id- Naucalpan de Juarez, Estado de Mexico, Mexico- Job TypeFull-timeWork Your Magic with usReady to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Estamos en búsqueda de un Especialista en Validación de Aseguramiento de Calidad que contribuya directamente a la productividad y excelencia de nuestra planta, asegurando procesos robustos, confiables y alineados con los más altos estándares internacionales.

Tu rol

- Ejecución de simulaciones de proceso aséptico para asegurar calidad preventiva.- Ejecución y mantenimiento del Plan Maestro de Validación (PMV).- Validación de procesos estériles, revisiones anuales de producto y perfiles térmicos.- Gestión de recursos internos y externos para garantizar ejecución oportuna.- Análisis de datos, identificación de tendencias y propuesta de CAPAs.- Garantizar integridad de datos y confiabilidad de sistemas.- Desarrollo de planes de contingencia para continuidad del negocio.- Monitoreo de cumplimiento en normas de calidad, seguridad y medio ambiente.- Participación en iniciativas de mejora continua y controles de cambio.- Coordinación y capacitación en Integridad de Datos. Quién eres- Experiência mínima de 2 años en procesos asépticos y validación de equipos.- Conocimiento de normativas NOM-059, Eudralex, PDA, ISPE GAMP5, ICH y Farmacopea.- Manejo de sistemas de gestión de calidad como TrackWise y SAP.- Dominio en validación, calificación y análisis estadístico.- Deseable conocimiento en MES.- Inglés técnico (lectura).**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progressand become a part of a team that is dedicated to Sparking Discovery and Elevating HumanityUS Equal Employment OpportunitiesThe Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately.

The Company will not retaliate against any individual because they made a good faith report of discrimination.- Notice on Fraudulent Job OffersUnfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.

Applicant ProfileWHAT WE OFFERMoney makes the world go round. But at our company there’s more than just financial rewards.

We offer a range of attractive benefits to help you work your magic. Saving & FinacialOur 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.

We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future. Health & WellnessWe offer comprehensive medical, dental, & vision coverage-including v