DP2-2 配液准备工程师

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

   负责进行工器具清洗，湿热灭菌，配液等操作。 Be responsible for parts washing, autoclave and formulation operations during the production of glass bottles.

5. 05

   负责设计和撰写生产过程中批生产记录及设备使用台帐。 Responsible for the design, preparation, and review of batch manufacturing records (BMRs) and equipment usage logs for manufacturing operations.

6. 06

   负责新设备引入的验证文件的起草和审核 Responsible for drafting, reviewing, and maintaining qualification and validation documents associated with new equipment introduction projects.

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

   负责所在区域的设计图纸审核，现场规划，以及设备的现场验证组织和协调 Responsible for reviewing design drawings, planning site layouts within the assigned area, and organizing and coordinating on-site equipment qualification and validation activities, including installation, commissioning, and qualification execution.

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，支持其他基地的生产活动。 Additional matters arranged by the Executive Director include, but are not limited to, supporting other site manufacturing activities.

(e.g.: working time, special skills) 至少2-3年GMP生产经验，具有制剂清洗机，灭菌柜，配液生产操作的相关知识/经验, 有新建厂房的经验，了解并熟悉新设备引入和验证流程 A minimum of 2-3 years of GMP manufacturing experience is required, with demonstrated knowledge and hands-on experience in washer,autoclave, formulation operations. Candidates should have experience in greenfield facility projects and be familiar with the equipment introduction, commissioning, qualification, and validation processes for aseptic filling lines.