QA Specialist(shift)
职位编号 C11130024
行业 制药/医疗
类型 医疗设备/器械
所在地 苏州
职位描述:

1、To be in process control during production area of packaging line;
2、To conduct floor audit and verify the identity of in-process control including lot No, expiry date and filling weight, etc and check appearance of packaging materials and finished product;
3、To write down in-process results on batch records and review it for further process step;
4、To be responsible for confirmation of line clearance before and after production;
5、To be in charge of sampling and delivery to QC lab, house sample and generation of COA of in-process samples & finished products. To approve or reject the semi-products used in manufacturing of drug products;
6、Take samples according annual stability sampling plan;
7、Ensure the final package of each step meets the requirements of local government regulation and Lilly standards;
8、To conduct floor audit and verify the identity of in-process control including lot No, expiry date etc and check appearance of packaging materials and finished products to ensure these in-process checks conform to the applicable acceptance criteria;
9、Responsible for sampling of finished product and sample storage;
10、Participate and implement specific tasks regarding HSE and 5S activities;
11、To assume other tasks related to QA;
12、Participate in deviations, change controls and complaint investigation;
13、Archive the records and documentation related to duty;
14、Verify the issued batch record and packaging order to ensure it is printed clearly and completely as well as the correct version;
15、Verify the completed batch record and packaging order to ensure the data completeness and accuracy。

职位要求:

1、Associate degree or above, majored in pharmaceuticals, chemistry or related sciences; 
2、One to three years of experience in production or QA;
3、Capable of read in English;
4、License pharmacist, preferred。

 

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