Kinh nghiệm: Minimum of three years exposure of the same capacity
Yêu cầu bằng cấp: BS Pharmacy degree holder from medical universities. Must be a licensed pharmacist.
Số lượng cần tuyển: 2
Ngành nghề: Đăng ký thuốc
Địa điểm làm việc: Hà Nội
Chức vụ: Khác
Hình thức làm việc: Trực tiếp
Yêu cầu giới tính: Nam, Nu
Yêu cầu
- Documentation
• Monitoring and updating of distributor licenses, Marketing Authorization Certificate.
• Monitoring reports containing records of products with Batch Notification and Lot Release Certificate
- Coordinates with the concerned departments for the collection of data/information and preparation of the following reports. Monitors and maintains an up-to-date records of the same:
• Monitor and prepare CAPA Reports from Principal/Third party audits
• Conduct preliminary investigation and coordinate with principal to handle of Customer Complaints
• Monitor and follow up implementation of products changes relevant to regulatory requirements
• Conduct regular audit to Distributor warehouse to ensure compliance to good distribution practice is in place, e.g storage condition, documentation system, etc.
• Conduct regular product sampling from outlet to ensure compliance packaging labeling and to anticipate complain relevant to product quality.
- For finished product came from principal non Kalbe group/non indo product: how to ensure QA products in the market.
Quyền lợi
Chi tiết
- Ensure compliance for product in the market inline with regulation as set by FDA/local regulatory authority
- Support marketing team in term of promotion and advertising approval, hospital tender requirement
- As company representative, have a good communicate and build relationship with Regulatory Authority
- Responsible pharmacist for product registration in KI respective countries
