Hard and happy
Release time:
2020-08-14
works hard and happily
We QA are responsible for the product quality management of 8 production lines of Jinxi Factory. The products produced must meet the drug quality requirements. We are a quality control in the workshop. If we do not adhere to the principle and give the green light to some behaviors in the workshop, it is irresponsible.
QA Part I is not only responsible for the preparations for the certification and re-certification of GMP in Jinxi Factory, but also responsible for the daily supervision and material monitoring of the production process. Assist in the completion of defects that need to be rectified and regular inspection of clean areas; Review relevant SOP ; Check whether the drafting, revision and supplement of documents are carried out in accordance with regulations and whether they are filed in time; complete the change of main raw materials and packaging materials; handle user complaints and account registration; annual product quality review, etc.
At the end of January 12 , our site QA not only needs to complete the daily supervision of the production process, but also needs to complete the annual quality review of each product. At the end of the year, we need to collect the information involved in the review of each product: the basic situation of each product, the quality of production, the packaging of raw and auxiliary materials, the intermediate control of the production process, the control of key process parameters, the control of intermediate products, and the balance yield of materials; finished product inspection results review, public system review, OOS and OOT investigation, deviation investigation, stability investigation and adverse trend analysis, change control review, product return complaint recall adverse reaction, etc. These data need to be collected by each of us in various departments. This work must use computers. At this time, office computers will not be enough. We can only bring our laptops to use.
Our QA one is so hard and happy. (Huang Yiqin)
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