Tu Rol:

Apoyar al Gerente de Calidad en la ejecución de tareas de Calidad y Cumplimiento para la filial de México, garantizando el cumplimiento de los requisitos de Buenas Prácticas de Manufactura (BPM) y Buenas Prácticas de Distribución (BPD), así como de las normas locales, incluyendo NOM059, NOM072, NOM241 y NOM240.Apoyar en la implementación y monitoreo del Sistema de Gestión de Calidad y su mejora continua, alineado con la estrategia global de Operaciones de Atención Médica.Gestionar e informar sobre la liberación de productos, quejas, desviaciones, CAPA, control de cambios, y alertas de productos, incluyendo notificaciones a Cofepris.Asegurar que los documentos de productos devueltos estén disponibles en el EPR, y mantener registros e investigaciones de quejas a través de TrackWise.Gestionar el proceso de quejas, incluyendo investigación con los sitios asignados y retorno de muestras a los sitios de fabricación.Compilar, seguir y compartir informes de tendencias, proponiendo CAPAs en colaboración con las partes interesadas.Apoyar el proceso de lanzamiento de productos, asegurando la liberación final en los mercados locales (especialidades: endocrinología, neurología, fertilidad, oncología; medicina general: cuidado cardio metabólico).Evaluar devoluciones de productos y determinar su aptitud para ser revendidos o destruidos.Asistir en la preparación de presentaciones de capacitación sobre SOPs y WI’s relevantes de GxP.Reconocer y reportar eventos adversos, asegurando la comunicación con la Persona Responsable de Seguridad del Paciente Local (LPS).Asistir en el proceso de reconciliación de eventos adversos y quejas de productos.

 

 

Tu perfil:

Título en Farmacia, Química, Ciencias de la Vida, Farmacología, Medicina o disciplinas científicas afines.Entre 4 y 9 años de experiencia en la industria farmacéutica, preferiblemente en operaciones de fabricación/calidad o gestión de distribución.Experiencia en Buenas Prácticas de Distribución.Dominio de Microsoft Suite.Familiaridad con software como Veeva y ManGo y sistemas de gestión de documentos (altamente deseable).Experiencia con herramientas de análisis de datos como Power BI.Inglés avanzado (excluyente).SAP (excluyente)Trackwise (excuyente)

 

 

Support the Quality Manager in the performance of Quality and Compliance tasks for Mexico / Subsidiary with regards to GMP and GDP requirements (including Medical Device guidelines) as well as local regulation NOM-059-SSA1 “Buenas Prácticas de fabricación de Medicamentos”,  implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement. Tasks will include the management of product release (as applicable), documentation, metrics / trend reports for both complaints and deviations. In addition, this role will provide assistance with the management of complaint management activities e.g. reporting, trend analysis etc. Another key area of this role is the maintenance and creation of Standard Operating Procedures and Work Instructions, aligned with HCQ requirements; ensuring documents are available via Mango.

 

Key Responsibilities

Manage the Complaints Process including the investigation process. Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database TrackWise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses).Adherence to the Change Control and Deviation procedures including data entry into the electronic system, TrackWise.Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango.Release for Sale at Subsidiaries, if applicable: verification of relevant documents to confirm compliance of products received and on time local release for sale to market.Product Returns: assessment of product returns and supporting information to verify if products are suitable for return to saleable status or destruction.Management of quality activities impacted by FMD implementation for EU Subsidiaries (as applicable).Participate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary.Assist with preparing training presentations as needed e.g. for relevant GxP SOP’s & WI’s.Assist with audit management planning and execution including the tracking of CAPA plans through to closure.Assist with Risk Management activities.Actively participate in the company's Performance Management Process and Personal Development plan.Work within company Standard Operating Procedures, industry guidelines and apply the company's Values and Code of Conduct in daily duties and activities.To recognise a reportable Adverse Event (AE) or Safety Information and ensure the information is forwarded to the Local Patient Safety Person (LPS) in the company, Inc. within 24 hours.Assist with the Adverse Event / Product Complaint reconciliation process.Act as a local Quality Learning Coordinator (as applicable).Perform other functions and duties that may be assigned by the Quality Manager.Act as Product Crime Officer (as applicable).QA Specialist also acts as a local Product Crime Officer. PCO manages product crime incidents in accordance with corporate standards and local regulations.

 

Your Profile
Education

Years of Experience

Competencies:

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 progress!
 
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