制造技术员Ⅲ

工作目的

1. 01

   完成制造区域的工作。具备持续改进的意识，以提高个人与团队能力为目标。 Complete work in manufacturing area. Have continuous improvement awareness.Have the goal of improving individual and team capabilities.

2. 02

   具有良好的职业道德、敬业精神及团队协作精神，工作积极主动、责任心强。 Have good professional ethics, professionalism and teamwork spirit, work actively and have a strong sense of responsibility. 主要职责：

3. 01

   积极参与制造车间的日常工作。 Actively participate in the daily work of manufacturing workshop.

4. 02

   按生产计划保质保量完成生产任务；遵循GMP 规范的要求保证产品质量。 Finish the production task according to the production plan to ensure the quality and quantity; Follow GMP specification to ensure product quality.

5. 03

   负责制造区域和设备的操作和清洁，确保所用设备保持清洁和完好。 Responsible for the operation and cleaning of the manufacturing equipment to ensure that the equipment is kept clean and in good condition.

6. 04

   对于制造相关岗位（称量、制粒、过筛、混粉、压片、包衣、充填等）工艺及设备有一定的了解，至少有其中2个岗位的丰富操作经验。 Have a certain understanding of manufacturing related positions (weighing, granulation, sieving, blending, tablet pressing, coating, filling, etc.) process and equipment, at least 2 of them have rich operation experience.

7. 05

   能够辅助起草、升版SOP文件和WI文件，能够辅助完成偏差调查； Assist in drafting and upgrading SOP and WI documents, assist in deviation investigation;

8. 06

   能够掌握维修单申请流程；能够完成试机生产的申请流程； Be able to master the maintenance order application process; Be able to complete the application process of trial production;

9. 07

   遵守公司规章制度和GMP要求,并及时报告与GMP相背离的现象。 Comply with company regulations and GMP

and report any deviation from GMP.

8. 08

   遵循EHS 规范符合环境保护,员工职业保护和生产安全。 In accordance with EHS regulations to comply with environmental protection, employee occupational protection and production safety.

9. 09

   按照SOP要求及时准确地填写生产记录。 Fill in the production record timely and accurately according to SOP.

10. 10

    提出有建设性的建议并参与提高质量，效率，成本以及安全的项目。 Make constructive suggestions and participate in projects to improve quality, efficiency, cost and safety.

11. 11

    具有良好的安全意识和行为，以避免安全事故的发生。 Good safety awareness and behavior to avoid accidents.

12. 12

    服从直线经理安排的工作任务，包括培训等。 Obey the task assigned by line manager, including training, etc.

13. 13

    当任何违反公司政策、目标或要求的情况发生时要第一时间通知直线经理。 Inform line manager immediately of any violation of company policy, objectives and requirements. 工作要求：

14. 01

    本科以上学历，药学、生物制药、化学或相关专业 Bachelor’s degree or above in Pharmacy, Biopharmaceutical Sciences, Chemistry, or related majors.

15. 02

    制药行业2年以上工作经验 At least 2 years of working experience in pharmaceutical industry

16. 03

    良好的GMP知识 Good knowledge of GMP

17. 04

    良好的制药生产知识 Good knowledge of pharmaceutical production

18. 05

    设备操作动手能力较强 Strong skill of operating equipment

19. 06

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