生产专员

1.Accept training of Filling or Formulation SOPs（including site operations,records writing）.接受灌装或配液SOP的培训(包括岗位操作，记录填写)。

2.Clean / sanitize filling equipment(including filling isolators).

清洁/消毒灌装设备(包括灌装隔离器)。

3.Clean / sanitize formulation and filling areas / room spaces.

清洁/消毒配液和灌装区域/ 车间。

4.Receive filling and or Formulation consumables (e.g., gloves, gowns) from the warehouse into the manufacturing facility and transfer to the required areas.

接收从仓库转移到生产楼的灌装或配液耗材（如手套，洁净服），并转移到所需的区域。

5.Receive API Bulk formulation and filling materials (e.g., tubing, containers) from the warehouse and formulation into the manufacturing facility and transfer to the required areas in accordance with the batch records.接收从仓库转移到生产楼的原料药原液配液和灌装材料（例如，敷管，容器），并按照批记录的要求转移到所需的区域。 

6.Transfer equipment / equipment format parts for filling within the manufacturing facility

to the required areas for processing in accordance with the batch records.

在生产车间内按照批记录转移用于灌装的设备/设备配件至需要的区域。

7.Monitoring and perform environmental conditions using established monitoring system.

使用现行监控系统检测和执行环境条件。

8.Perform viable enviromental monitoring of the clean rooms.

执行洁净室内活性悬浮粒子环境监测。   

9. Perform non-viable enviromental monitoring of the clean rooms.

执行洁净室内非活性悬浮粒子环境监测。 

10.Monitoring the filling isolator system environmental conditions monitoring system.

监测灌装隔离器系统的环境条件监控系统。

11.Monitoring the filling isolator system non-viable environmental monitoring system.

监测灌装隔离器系统的环境监控系统。

12.Monitoring the filling isolator system viable environmental monitoring system.

监测灌装隔离器系统的活性悬浮粒子环境监控系统。

13.Assemble disposable filling or formulation equipment and set up filling equipment for processing in accordance with the batch records.

根据批次记录安装一次性灌装或配液设备，安装工艺灌装设备。 

14.Undertake product formulation and or filling in accordance with the batch records.

根据批次记录进行产品配液和/或灌装。 

15.Take samples of bulk formulation and or filling product in accordance with the batch records and transfer to QC Chemistry and QC Microbiology.

根据批次记录对原液配液和灌装产品进行取样，并转移至QC理化和QC微生物实验室。

16.Transfer the oversealled product to the packaging area.

转移轧盖结束的产品至包装区。

17.Undertake aseptic simulations of the formuation and or filling process.

承担配液和/或灌装工艺的无菌模拟。

18.Undertake line clearance of the process areas / room spaces.

承担工艺区/室清场。 

19.Complete batch records for the process as each step is completed.

每一步骤完成后完成工艺批次记录。 

20.Clean/sanitize, decontaminate the process equipment.

清洁/消毒，净化工艺设备。

21.Decontaminate the process areas / room spaces.

净化工艺区/室。 

22.Decontaminate equipment in accordance with the decontamination records.

按照净化记录的要求对设备进行清洁。

23.Take decontamination samples in accordance with the decontamination records.

按照净化记录进行清洁取样。

24.Transfer the decontaminated equipment to the WIP areas.

转移已清洁的设备至WIP区域。

25.Transfer waste to the waste management area.

转移废物到废物管理区域。

26.Support the routine preventative maintenance of the filling equipment.

为灌装设备的日常预防性维护提供支持。

27.Support the non-routine maintenance of the filling equipment.

为灌装设备的非日常维护提供支持。

28.Support process equipment qualification, validation and revalidation.

支持工艺设备确认，验证和再验证。　　

29.Inspection of all equipment and stations Pre and Post set ups after change overs.

在设备运行前后检查所有组装调整后的设备。   

30.Follow gowning requirements in according Standard Operating Procedures.

按照标准操作规程遵守更衣要求。   

31.Verification of all kinds of associated material.