岗位职责：
1.Ensure that all production personnel are appropriately trained for their positions.

确保所有的生产计划人员已接受恰当的岗位培训。

2.Prepare, review, implement and maintain Production Planning SOPs.

起草、审核、实施和维护生产计划SOP。

3.As required, participate in the Weekly Operations Organization Meeting to review trended Manufacturing data, staff requirements and quality issues.

根据需求，参加每周的运营部门会议以审核生产数据趋势分析、员工要求和质量议题。

4.Assist with the prepare production plan for products to be manufactured against the monthly requirements of the Business Department.

根据业务部门的月度需求，协助准备产品的生产计划。

5.Assist with the tracking of the product manufactured against the production targets and product mixes defined.

根据定义的生产目标和产品组合，协助跟踪生产的产品。

6.Through the Business Department assist with the ordering of manufacturing consumables, components and materials required against the monthly requirements of the Business Department and the production targets and product mixes defined in the Annual Plan.

根据业务部门的月度需求和年度计划中定义的生产目标和产品组合，通过业务部门协助订购所需的生产耗材，部件和材料。

7.Assist with the scheduling of manufacturing resources training and retraining.

协助安排生产资源培训和再培训。

8.Assist with the scheduling of equipment & systems calibration and systems preventative maintenance.

协助安排设备和系统的校准和系统的预防性维护。

9. Assist with the Schedule batch manufacture date(s).

协助安排批次生产日期。

10.Track equipment & systems uptime availability, faults and failures.

追踪设备&系统的运行时间的有效性、故障和失效。

11. Assist with the tracking of manufacturing process yields and reject data.

协助跟踪生产工艺产量和拒收数据。

12.Ensure that the required Manufacturing resources are available to meet production targets while maintaining product quality.

确保必需的生产资源的有效性，在保证产品质量的同时符合生产目标。

13.Provide technical mentorship to Manufacturing staff.

为生产部员工提供技术辅导人员。

14.Write, review and approve SOPs generated and required by Manufacturing.

编写、审查和批准生产部生成和需要的SOP。

15.Report critical quality / compliance issues to Executive Management immediately.

及时向执行管理层报告关键的质量/符合性问题。

16.Work with the Quality, Operations and GMP Accounting Organizations to ensure that the OncoGenerix systems are operating in compliance.

和质量部、运营部和GMP财务部共同确保基纳瑞克斯的体系合规运营。

17.Where appropriate participate in risk management / risk review meetings, failure investigations associated with the Manufacturing Department.

在适当的参与风险管理/风险评估会议，与制造部门相关的故障调查。

18.Assist with the manufacturing activities for new product development.

协助新产品开发的生产活动。

19.When require assist with the implementing of production plans for site operations ensuring the product changeover is appropriate to guarantee non-interrupted supply of marketed products.

负责制定和实施公司运营的生产计划，确保通过恰当的产品轮换生产方式，保证上市产品的无间断供应。

20.Responsible for managing the formulation and filling operation of products are performed and documented accordantly.

负责管理确保产品的配液及灌装操作和记录一致。

21.Responsible for implementing and managing an effective cleaning process and product changeover programs to prevent the product contamination and cross contamination during product manufacture.

负责执行和管理清洗过程的有效性及产品运转流程，防止在产品的生产制造过程中产生污染和交叉污染。

22.Responsible for reviewing product batch production records, ensuring the batch production records are accurate, complete and correct.

负责公司各产品批生产记录的审核工作，确保各产品批生产记录的准确、完整、正确。

23.Responsible for the monitoring of the production area and equipment temperature, humidity, viable, Non-viable environmental monitoring systems.

负责监测生产区域和设备的温度、湿度、可行、不可行的环境监测系统。

24.Responsible to ensure the cleaning, sanitization and or decontamination of the cleanroom areas and equipment are performed and properly documented.

负责确保洁净区和设备的清洗、消毒或净化操作实施且正确的记录。

25.Oversee the process formulation and filling process (materials processing, parts and set up assembling, process sampling, area/ line clearance) is accordance with the batch records.

监督工艺配方和灌装过程（物料的加工，零件的装配，过程取样，区域/线的间隙）符合批记录。

26.Perform other activities assigned by management.