DP 2-制剂无菌灌装助理工程师/工程师

Job Responsibility

1. 01

   熟悉注射剂生产设备的原理、会熟练操作设备。 Be familiar with the principle of injection production equipment and be skilled in operating equipment.

2. 02

   熟悉并掌握无菌制剂生产工艺，理解并遵守无菌生产区的出入及更衣和无菌区操作准则。 Be familiar with and master the manufacturing process of sterile preparations, understand and abide by the access and gowning of aseptic production areas and the operating guidelines for aseptic areas.

3. 03

   负责设备的日常维护并协助维修人员对设备进行检修及校验，验证。 Be responsible for the daily maintenance of equipment and assist the maintenance personnel to overhaul, calibrate and verify the equipment.

4. 04

   负责进行西林瓶针剂生产过程的灌装等操作。 Be responsible for filling operations during the production of glass bottles.

5. 05

   负责生产过程中批生产记录及设备使用台帐的填写。 Be responsible for filling in batch production records and equipment use ledger during production.

6. 06

   负责所在洁净区域的清洁，消毒。 Be responsible for the cleaning and disinfection of the clean area where it is located.

7. 07

   负责偏差调查，变更等文件报告的起草。 Be responsible for drafting deviation investigation, change and other document reports.

8. 08

   负责生产所需的物料的管理及所生产成品的出入库。 be responsible for the management of the materials required for production and the warehousing and delivery of the finished products produced.

9. 09

   生产过程中及日常行为严格遵守EHS、IP保护等合规准则。 Strictly abide by EHS, IP protection and other compliance standards in the production process and daily behaviors.

10. 10

    执行主管安排的其他事项包括但不限于，支持其他基地目检/贴签/包装等活动。 Additional matters arranged by the Executive Director include, but are not limited to, supporting other site visual inspection/labeling/packaging activities.

(e.g.: working time, special skills) 至少2-3年GMP生产经验，具有无菌灌装生产操作的相关知识/经验 At least 2–3 years of GMP manufacturing/production experience, with relevant knowledge and/or hands-on experience in aseptic filling operations.