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Sanofi logo
赛诺菲
intern product complaint manufacturing and supply services japanese speaker
立即应聘

intern product complaint manufacturing and supply services japanese speaker

发布于 大约 7 小时前

实习/见习

Petaling Jaya, Malaysia
无经验要求
实习生
仅现场办公
学历未注明
质量管理
Japanese
GxP
Cross-Functional Collaboration
Documentation

AI 估算 · 2k–4k

Intern position in Malaysia; salary estimated based on local market rates and multinational company standards.

职位详情

关于这个职位

This internship at Sanofi focuses on handling product technical complaints for medical devices, pharmaceuticals, and biologics, with a requirement for Japanese language proficiency. You will work within the manufacturing and supply services team, ensuring compliance with regulatory standards and collaborating across departments.

工作职责

Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.

Proficient in Japanese, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries.
Collaborate with internal/external stakeholders via cross-functional teams (Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field Alert Reporting, risk management departments, etc.) for complaint management.
Conduct management of complaints into the proper database and perform assessment, ensuring timely processing as per defined scope.
Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
Participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback.
Ensure the compliance of documentation and all Quality processes according to applicable regulations/Sanofi standards. Handle Quality Management System (QMS) records.
Ensure the documentation of Hub-related GxP activities.
Proactively identify areas for improvement and support on the implementation.
Abide any other responsibilities as assigned/aligned by manager.
For MCCQ – Regional hubs:
Act as a Regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management.
Determine if the inquiry is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation, customer service or Field Alert Reporting-related information.
Appropriate handling and closure of information considered as Non-PTC at Regional Level.
Capture and document sample information into the proper fields of the system.
Ensure to complete all the required information and forward the complaint to Global Hub (including translation, if applicable).
Health authority called-in complaints, prioritized complaints, and suspected counterfeit complaints are handled with utmost urgency.
Ensure acknowledgement of Complaint. Communicate with the complainant for any other request/ additional information.
Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

AI 洞察

优缺点分析

优点

  • Hands-on experience in a multinational pharmaceutical company's quality operations.
  • Develop valuable regulatory compliance knowledge applicable to medical devices and drugs.
  • Opportunity to use Japanese language skills in a professional business setting.
  • Structured training and exposure to cross-functional collaboration.
  • The role involves repetitive documentation tasks that require high attention to detail.
  • Need to quickly learn complex regulatory guidelines and company procedures.
  • Work is office-based with limited flexibility
  • may require handling urgent complaints under time pressure.
  • This role is ideal for Japanese-speaking students or recent graduates interested in quality assurance, regulatory affairs, or supply chain within the pharmaceutical industry.

缺点 / 挑战

暂无明显挑战项

角色解读

  • Gain foundational experience in pharmaceutical quality and compliance, opening doors to QA or Regulatory roles.
  • Opportunities to advance into specialized complaint handling or pharmacovigilance positions.
  • International company exposure can lead to global career development within Sanofi or other pharmaceutical firms.
  • Process product technical complaints, ensuring compliance with regulatory standards and accurate documentation.
  • Utilize Japanese language skills to interpret and translate complaints from Japanese-speaking countries.
  • Collaborate with cross-functional teams including manufacturing, pharmacovigilance, and regulatory affairs.
  • Manage complaint records in the Quality Management System and support continuous improvement initiatives.
  • Fluency in Japanese (reading, writing, speaking) is essential for accurate complaint handling.
  • Basic understanding of quality management systems and regulatory requirements for medical products.
  • Strong attention to detail and documentation skills to maintain compliance.
  • Effective communication and teamwork abilities to collaborate with global stakeholders.

申请策略

  • Tailor your cover letter to express interest in quality assurance and highlight your bilingual ability.
  • Research Sanofi's product portfolio and recent news to demonstrate genuine interest in the company.
  • Emphasize Japanese language proficiency with certification or study abroad experience.
  • Highlight any coursework or projects related to quality management, pharmaceuticals, or life sciences.
  • Showcase attention to detail through examples of documentation or data management tasks.
  • Include any previous internship or part-time roles that demonstrate teamwork and communication.
  • Familiarize yourself with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Learn basic pharmacovigilance concepts and the difference between adverse events and complaints.

面试指南

  • Use the STAR method (Situation, Task, Action, Result) for behavioral questions. For technical questions, structure your answer by first explaining the concept, then applying it to the role, and finally asking clarifying questions if needed.
  • Can you describe your experience with Japanese language in an academic or professional setting?
  • How would you handle a product complaint that arrives in Japanese and needs to be processed urgently?
  • What is your understanding of a Quality Management System (QMS) and its importance?
  • Tell us about a time you had to manage multiple tasks with strict deadlines.
  • Are you familiar with regulatory requirements for medical devices or pharmaceuticals?
  • Review basic pharmaceutical regulations (e.g., FDA, EMA, MHRA) and understand the complaint handling process.
  • Prepare a brief self-introduction in Japanese to showcase language skills.

职位点评

60
综合评分

Pharma QA internship in Malaysia with Japanese language requirement, offering solid learning but moderate pay and on-site work.

更适合这类人
This internship is best suited for candidates prioritizing skill development and industry exposure over immediate financial compensation.
表现最好
成长发展
相对薄弱
薪资福利
薪资福利40
成长发展75
工作生活60
使命价值65

薪资福利

40较低

As an internship, the salary is modest and typical for entry-level positions in Malaysia, but the company provides a structured learning environment. Benefits are not explicitly stated.

薪资信号未披露(AI估算:2K-4K/月)

成长发展

75中等

The role offers significant learning opportunities in quality management, regulatory compliance, and cross-functional collaboration. Training is provided, and the intern gains practical experience in a global pharmaceutical company.

技术前沿传统/成熟技术
技术栈GxP、QMS、Pharmacovigilance
成长机会training plan、continuous improvement
业务类型ambiguous

工作生活

60中等

The internship requires on-site presence in Petaling Jaya, Malaysia, with standard office hours. There is no indication of remote work flexibility. The location is in a suburban area.

工作模式仅现场办公
办公地点科技园/产业园
加班情况未提及(无法判断)

使命价值

65中等

Working in a pharmaceutical company that produces life-saving drugs and medical devices provides a sense of purpose. The role contributes to patient safety by ensuring product quality and complaint handling.

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patient safety (implied)
创新程度稳健跟随主流
Watch Jobs
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我们专注于实时追踪各企业最新职位动态,帮助您节省求职时间,快速找到理想工作机会。

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  • 浏览职位
  • 数据统计
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  • 数据方法论
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  • 免费试用
  • 价格方案
  • 常见问题
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微信公众号小红书淘宝店铺

© 2026 Watch Jobs. 保留所有权利

Created by jianglicat - 讲礼猫

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