工作内容CONTENT
1.审核生产的各种操作规程，确保员工严格执行与生产操作相关的各种操作规程。
Review SOP of production to ensure that Operator strictly implement SOP related to production operations.
2.负责人员培训，确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容。
Responsible for personnel training, ensure that production related personnel have the necessary pre-job training and continuous training, and adjust the training content according to actual needs.
3.审核产品工艺试制方案和报告。
Review the study protocol and report for the process of drug product.
4.审核工艺验证和设备验证方案和报告，确保完成必要的工艺验证工作。
Review the validation protocol and report for the production process. Ensure necessary process validation is completed.
5.审核和批准生产计划。确保各项工作具备生产条件。
Review and approve the schedule of manufacturing. Ensure that all work conditions are in place.
6.审核制剂生产工艺规程，并确保药品按照批准的工艺规程生产、储存，以保证药品质量。
Review the instructions for the production of drug product. And to ensure that the drug in accordance with the approved process procedures production, storage, to ensure the quality of drugs.
7.确保按照已批准的生产工艺规程进行药品的生产。
Produce DP according to approved instructions for the production of drug product.
8.审核所有的批生产和批包装记录，确保参与人员均经过指定人员审核并送交质量管理部门。
Review all production batch records and ensure that all participants are reviewed by designated personnel and sent to quality management.
9.确保所有的生产偏差都已报告、评估，关键的偏差已作了调查，并记录了结论。
Make sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.
10.确保生产设施是清洁的，并在必要时消毒。
Make sure that production facilities are clean and when appropriate disinfected.
11.确保厂房和设备的维护保养，并有记录。
Make sure that the facilities and equipment are maintained and records kept.
12.协助培训管理员的相关培训工作。
Assist the training administrator in related training work
13.对产品、工艺或设备的变更做出评估。
Evaluate proposed changes in product, process or equipment.
教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION
1.应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格）。
Bachelor degree or above in pharmacy or related majors (or intermediate professional technical title or licensed pharmacist qualification).
2.具有至少五年从事口服固体制剂商业化生产管理的实践经验，经历过NMPH, FDA和欧盟GMP审计。
At least five years of experience in commercial OSD manufacturing, involved in GMP Audit of NMPH, FDA and EMA.
3.接受过与所生产产品相关的专业知识培训。
Have received professional knowledge training related to the products produced.
4.具有一定的英语能力，应能与国外客户进行有效的沟通。
Have a certain English ability, and should be able to communicate effectively with foreign clients.