一、工作職責(zé):
1.組織實(shí)施物理和化學(xué)相關(guān)檢測(cè)項(xiàng)目（如色譜類、光譜類、電化學(xué)類以及普通物化反應(yīng)類）的檢驗(yàn)。根據(jù)檢測(cè)計(jì)劃，按期完成檢驗(yàn)工作。
Organize and implement experimental activities on testing related to physical and chemical items, e.g., chromatography, spectroscopy, electrochemistry, and general physicochemical reactions. Complete the testing work on schedule according to plan.
2.負(fù)責(zé)起草操作類的SOPs，包括分析方法、儀器操作。
Responsible for drafting SOPs related to method and instrument operation.
3.負(fù)責(zé)理化相關(guān)分析方法驗(yàn)證方案報(bào)告的起草和審核工作，如HPLC\GC\UV\水分\電泳等儀器分析方法。
Responsible for drafting and reviewing validation protocol\reports of analytical method related to physicochemical method. For example: Instrumental analytical methods such as HPLC\GC\UV\Moisture\Electrophoresis etc.
4.檢驗(yàn)成本的核算。
Responsible for carrying out the account of testing costs.
5.負(fù)責(zé)管理、維護(hù)保養(yǎng)檢驗(yàn)設(shè)備，確保檢驗(yàn)設(shè)備可正常運(yùn)行且在有效期內(nèi)。協(xié)助主管完成對(duì)新設(shè)備的安裝、調(diào)試、校準(zhǔn)、確認(rèn)以及設(shè)備檔案的建立工作。
Responsible for the management and maintenance of instruments to ensure that the instruments can be running properly and within the validity period. Assist supervisors in the installation, commissioning, calibration, and validation of new instruments as well as the creation of equipment files.
6.負(fù)責(zé)在管轄區(qū)內(nèi)推行5S的管理，并負(fù)責(zé)管理區(qū)域內(nèi)的檢驗(yàn)設(shè)備，組織人員開展設(shè)備維護(hù)保養(yǎng)工作。確保實(shí)驗(yàn)室現(xiàn)場(chǎng)設(shè)備可正常運(yùn)行，在有效期內(nèi)。
Responsible for the implementation of 5S management and equipment management in the jurisdiction of the area, organizing personnel to carry out maintenance of equipment. To ensure that equipment in QC can be operated normally, within the validity period.
7.完成QC經(jīng)理分配的其他工作和職責(zé)。
Any other job and responsibilities assigned by QC manager.
二、任職資格:
1.生物藥品相關(guān)經(jīng)驗(yàn)，抗體藥優(yōu)先，有2年以上團(tuán)隊(duì)管理經(jīng)驗(yàn)
2.負(fù)責(zé)保證小組內(nèi)所有成員的活動(dòng)符合GMP的要求。
Be responsible for assuring that all the activities for group members are in line with GMP requirement.
3.嚴(yán)格按SOP進(jìn)行操作，并真實(shí)地、及時(shí)地、準(zhǔn)確地完成記錄填寫和數(shù)據(jù)處理，及時(shí)歸檔檢驗(yàn)記錄。
Operations in strict accordance with SOPs, and to complete record filling and data processing truthfully, timely and accurately, and to file analytical records in a timely.
4.組織人員完成驗(yàn)證相關(guān)工作；
Organize and implement method validations;
5.協(xié)助QC經(jīng)理，對(duì)相關(guān)人員進(jìn)行上崗前培訓(xùn)和繼續(xù)培訓(xùn)。
Assist the QC manager to conduct pre-service training and continuous training for relevant personnel.
6.組織實(shí)驗(yàn)室的OOS、偏差調(diào)查，以及相關(guān)的變更控制；
Responsible for conducting investigations of OOS , deviations and related change control;