Đăng xuất
Việc làm Hồ Chí Minh
Quality Regulatory Affairs Assistant
Mô tả công việc
Department: Quality & Regulatory Affairs
Purpose of Function:
Support & perform regulatory & quality tasks as assigned by QRA Specialist in full compliance with local regulations.
Tasks and Responsibilities:
1. Regulatory Affairs/ Product Registration
• Prepare, submit and follow up for product approvals and registrations in full compliance with local regulations while building and maintaining good relation with health authorities
• Work with internal departments to support Drager’s product registration needs such as consolidating Vietnamese Instructions for Use/Quick guides, and making Vietnamese labels
• Work with external stakeholders such as local RA partners engaged in the registration process
• Support in tender requests, customer inquiries for QRA issues; reporting variations, and other reporting to authorities.
2. Intergrated System Management & Quality Affairs
• Support Integrated Management Systems: field actions, corrective action, product recalls if there is, advisory/warning notices, customer complaints, non-conforming products - including manage internal quality systems
• Implement and maintain effective controls for non-conforming product handling, reporting, labelling and disposition
• Support internal & external audits by notified bodies in collaboration with Regional Quality Manager and elimination of findings with appropriate immediate actions, corrective actions and effectiveness checks
3. Occupational Health & Safety, Environmental System
• Maintain and monitor library of regulations, policies, standards, and other quality, occupational HSE system documentation as required, online and offline
• Coordinate related events and trainings, consolidate HSE data, register incident and accident, incident investigations if there is
4. Other assigments by QRA Specialist
• Administrative tasks
Reporting Relationships:
• Functionally reports to: Senior QRA Specialist
Yêu cầu ứng viên
Education: College degree, vocational training or comparable business experience, medical/technical background prefered but not complusory
Related Experience:
1. Desirable: Minimum 1 years of working experience.
2. Preferable: Experience in registration, or working with authorities, or QA (ISO 9001 or ISO 13485 preferred)
Skills, Special Competencies, or Certifications:
1. Desirable:
• Proactive
• Detail-orientated
• Patient, hardworking
• Good comprehension & writing skill of English
• Expertise in MS Office (Word, Excel)
2. Preferable:
• Strong communication skills
• Problem solving skill
General Requirements:
All employees are expected to:
- Act as an ambassador of and in accordance with the company’s Guiding Principles.
- Adhere to the company’s Principles of Business and Conduct
- Demonstrate good judgment, and respect the confidentiality of company and personnel information.
- Deal professionally and courteously with all internal and/or external contacts.
- Seek guidance and direction as necessary in the performance of duties.
Quyền lợi/Phúc lợi
- Competitive salary and bonus
- Social insurance, health insurance, unemployment insurance according to Labor Laws
- Professional, dynamic working environment
Địa điểm làm việc
- Thành phố Hà Nội
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| Quy mô: | Chưa cập nhật |
| Lĩnh vực: | Chưa cập nhật |
| Địa chỉ: | 41-43 Nguyễn Cơ Thạch, Phường An Lợi Đông, Quận 2 (Hết hiệu lực), TP Hồ Chí Minh |
| Tên công ty: | Công ty TNHH Draeger Việt Nam |
| Quy mô: | Chưa cập nhật |
| Lĩnh vực: | Chưa cập nhật |
| Địa chỉ: | 41-43 Nguyễn Cơ Thạch, Phường An Lợi Đông, Quận 2 (Hết hiệu lực), TP Hồ Chí Minh |
| Ngày đăng tuyển: | 06/09/2018 |
| Cấp bậc: | Mới tốt nghiệp |
| Học vấn: | Cao đẳng |
| Số lượng tuyển: | 0 |
| Độ tuổi: | Không yêu cầu |
| Giới tính: | Không yêu cầu |
| Hình thức làm việc: | Toàn thời gian |
Thông báo
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