QA Specialist(Materials)
职位编号 C03140045
行业 制药/医疗
类型 制药/生物工程
所在地 苏州
职位描述:

1、Work with procurement and TS/MS on the list of consumables and materials to be used in the filling process;
2、Manage the risk assessment and classification (Low, Medium, High risk) of the materials and vendors per the Lilly Quality System;
3、Based on the risk assessment, work with QA, TS/MS, and Operations to obtain the appropriate information and qualify the material or vendor;
4、Be responsible for management of Suzhou East Lake Filling site GMP service providers, including management of the GMP Service Provider list and qualification documentation;
5、Responsible for the temperature control management of materials and products during storage and distribution;
6、Responsible for review the temperature data with the authority to determine whether it is suitable for use or not;
7、Make sure the quality of incoming materials is compliant, and then release the materials;
8、Responsible for review the incoming materials inspection results and has the authority to determine whether it is suitable for use or not;
9、To be responsible to build up quality culture;
10、To assume other tasks related to QA。

职位要求:

1、Bachelor degree or above in Pharmaceuticals or science related field;
2、Understanding of GMP with previous experience in Pharmaceutical production or QA;
3、Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution;
4、Interpersonal skills including working multinationally and communicating proactively;
5、Minimal travel but ability for some business trips to the US or Europe。

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