默克药厂
Especialista de Calidad
Especialista de Calidad
发布于 大约 2 个月前普通员工/个人贡献者
Carlos Spegazzini, Buenos Aires, Argentina
中级经验
全职员工
仅现场办公
本科
质量管理
ISO 9001
CAPA
GDP
Risk Management
AI 估算 · 10k–20k
中等经验质量专家，跨国药企，阿根廷薪资水平换算人民币约1-2万，含13薪
职位详情
关于这个职位
This role focuses on implementing and leading the Quality Management System for Life Science in Chile and Argentina, ensuring GDP compliance, managing key quality processes like risk management and CAPA, and leading internal and external audits. You will act as the authorized person for product release and collaborate with regulatory and logistics teams.
最低要求
Formación Académica: profesionales graduados en Química, Ciencias Químicas, Farmacia o carreras de grado relacionadas (excluyente).
Experiencia mínima de 3 años en tareas relacionadas con el Aseguramiento o Gestión de Calidad (excluyente).
Se requiere experiencia comprobable en auditorías bajo políticas de calidad, conocimiento operativo de centros de distribución y manejo de la norma ISO 9001.
Conocimientos Específicos: sólido conocimiento en Buenas Prácticas de Distribución.
Idiomas: nivel de inglés intermedio/avanzado (excluyente).
工作职责
Implementar y liderar el Sistema de Gestión de Calidad (SGC) de Life Science y los requerimientos de la compañía a nivel local (Chile y Argentina).
Garantizar el cumplimiento de las Buenas Prácticas de Distribución (GDP) y las normativas vigentes en el manejo, almacenamiento y envío de mercancías.
Gestionar procesos clave de calidad, incluyendo Gestión de Riesgos, Control de Cambios, Desviaciones, Planes CAPA, Integridad de Datos y Gestión de Quejas.
Liderar auditorías internas (autoinspecciones) y coordinar la recepción de auditorías externas (clientes, proveedores, organismos de certificación ISO 9001 y autoridades regulatorias).
Supervisar y aprobar registros críticos como reportes de control de plagas, certificados de calibración, mapeos de temperatura y reportes de calificación.
Actuar como persona autorizada para la liberación de productos devueltos y la aprobación de desviaciones por excursiones de temperatura.
Colaborar estrechamente con las áreas de Asuntos Regulatorios, Trade Compliance y Logística para asegurar la alineación de procesos y la continuidad del negocio.
Monitorear e informar oportunamente los indicadores de gestión de calidad para la revisión por la dirección y la mejora continua de los procesos.
AI 洞察
优缺点分析
优点
- Work for a global top-tier pharmaceutical company with strong brand and resources.
- Gain deep expertise in quality systems and regulatory compliance across two countries.
- Opportunity to lead audits and interact with international stakeholders, enhancing professional network.
- Requires handling multiple regulatory frameworks (Chile and Argentina) which can be complex.
- Responsibility for product release and temperature excursion decisions carries high accountability.
- Must travel as per organizational needs, which may affect work-life balance.
- This role suits quality professionals with at least 3 years of experience, strong in GDP and ISO 9001, who enjoy process improvement and regulatory compliance in a multinational environment.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress to Quality Manager or Regional Quality Lead within the organization.
- Develop expertise in regulatory affairs and compliance across different countries.
- Opportunity to expand into broader operational roles given the cross-functional collaboration.
- Implement and lead the Quality Management System for Life Science in Chile and Argentina.
- Ensure GDP compliance for handling, storage, and shipment of goods.
- Manage key quality processes: risk management, change control, deviations, CAPA, data integrity, and complaints.
- Lead internal audits and coordinate external audits from clients, suppliers, and regulators.
- Solid knowledge of GDP and ISO 9001 standards.
- Experience in quality assurance/management within distribution centers.
- Strong analytical and decision-making abilities.
- Intermediate to advanced English proficiency.
申请策略
- Tailor your application to show understanding of both life science and distribution quality.
- Prepare to discuss how you have handled audit findings and implemented corrective actions.
- Emphasize experience with quality management systems, especially GDP and ISO 9001.
- Highlight specific examples of leading internal audits and managing CAPA processes.
- Show proficiency in English and any experience working across multiple countries or regions.
- Include details of working in distribution centers or logistics environments.
- Brush up on data integrity principles and risk management methodologies.
- Consider obtaining additional certifications in quality management (e.g., CQA, CQP).
面试指南
- Use the STAR method: Situation, Task, Action, Result for behavioral questions.
- For technical questions, explain the principle, your approach, and a concrete example.
- Emphasize cross-functional collaboration and decision-making under pressure.
- Describe your experience with GDP and how you ensure compliance in a distribution center.
- Can you walk me through a CAPA implementation you led?
- How do you handle a temperature excursion? What steps do you take?
- Tell me about a time you had to manage an external audit. What was your role?
- How do you prioritize and manage multiple quality processes (risk, change control, deviations)?
职位点评
69
综合评分
Stable multinational quality role with high purpose, moderate compensation, strong development, but limited work-life flexibility.
更适合这类人
This position is ideal for quality professionals who prioritize meaningful work in healthcare, value stability and skill development, and are willing to work on-site with occasional travel.
表现最好
使命价值
相对薄弱
工作生活
薪资福利70
成长发展75
工作生活50
使命价值80
薪资福利
70中等
The position offers a competitive salary for the region and comes with the stability of a multinational giant, but specifics on bonuses or benefits are not disclosed in the JD.
薪资信号未披露（AI估算：10K-20K/月）
成长发展
75中等
The role provides substantial skill growth in quality systems, regulatory affairs, and auditing, with exposure to international standards and cross-functional collaboration. However, explicit promotion paths or training programs are not mentioned.
技术前沿传统/成熟技术
技术栈GDP、ISO 9001、CAPA、Data Integrity、Risk Management
业务类型ambiguous
工作生活
50较低
The role requires on-site work at a specific location (Carlos Spegazzini) and travel, with no mention of flexible hours or remote work. The office is in a suburban industrial area.
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
80较高
The role contributes to healthcare and life science quality, ensuring safe distribution of medical products. The company emphasizes innovation and improving lives, aligning with a strong sense of purpose.
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号enrich the life of people with solutions in Healthcare, Life Science and Electronics
创新程度积极采用新技术
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