職責Responsibilities：
a. 在QC經(jīng)理的指導下，負責配樣室、儀器室、液相室、氣相室、理化實驗室及穩(wěn)定性實驗室的維護管理；
a. Under the guidance of the QC Manager, manage and maintain preparation rooms, instrument rooms, HPLC laboratories, GC laboratories, physicochemical laboratories, and stability testing laboratories;
b. 負責指導液相QC、氣相QC、理化QC等人員的日常工作，進行績效考核和評價；
b. Guide the daily work of HPLC QC, GC QC, and physicochemical QC staff, conducting performance evaluations;
c. 負責分析儀器的使用、維護、確認及期間核查的培訓工作；
c. Conduct training on the use, maintenance, qualification, and periodic verification of analytical instruments;
d. 負責檢查質量控制部分析儀器的日常管理和運行，確保儀器正常運行并符合文件和GMP的要求；
d. Monitor the daily management and operation of analytical instruments in the quality control department to ensure they operate correctly and comply with documentation and GMP requirements;
e. 負責指導部門儀器的定期維護、維修、驗證、確認及期間核查、校準等工作；
e. Guide regular maintenance, repair, validation, qualification, periodic verification, and calibration of departmental instruments;
f. 作為QC部門文件管理員協(xié)助QC經(jīng)理進行部門檔案管理工作；
f. Serve as a document administrator for the QC department, assisting the QC Manager in managing departmental records;
g. 負責進行QC實驗室運行的日常監(jiān)督、檢查工作；
g. Oversee the daily supervision and inspection of QC laboratory operations;
h. 復核分析方法轉移/確認/驗證方案及報告，帶領QC人員完成分析方法轉移/確認/驗證并進行記錄復核；
h. Review analysis method transfer/validation protocols and reports, leading QC staff in executing method transfers/validations and reviewing records;
i. 指導QC人員完成產(chǎn)品相關原輔料、包裝材料的放行檢測并進行記錄和COA復核。
i. Guide QC staff in performing release testing for raw materials, packaging materials, and intermediates, reviewing records and Certificates of Analysis (COAs);
j. 指導QC人員完成分析方法開發(fā)、驗證工作，審核開發(fā)報告、驗證方案和報告。
j. Guide QC staff in developing and validating analysis methods, reviewing development reports, validation protocols, and reports;
k. 指導QC人員完成產(chǎn)品相關反應監(jiān)控、中間體、原料藥檢測并進行記錄復核和COA；
k. Guide QC staff in monitoring reactions, testing intermediates and APIs, and reviewing records and COAs;
l. 復核穩(wěn)定性試驗方案，帶領QC人員完成穩(wěn)定性試驗并進行記錄及報告復核；
l. Review stability study protocols, lead QC staff in completing stability studies, and review records and reports;
m. 負責參與制定原輔料、中間體、包裝材料質量標準和檢驗方法操作規(guī)程及檢驗記錄；
m. Participate in establishing quality standards and SOPs for raw materials, intermediates, and packaging materials, as well as inspection records;
n. 復核原輔料、中間體、包裝材料質量標準和檢驗方法操作規(guī)程及檢驗記錄；
n. Review quality standards and SOPs for raw materials, intermediates, and packaging materials, as well as inspection records;
o. 參與和支持生產(chǎn)工藝驗證，清潔驗證工作；
o. Participate in and support process validation and cleaning validation activities;
p. 協(xié)助QC經(jīng)理完成其他事務。
p. Assist the QC Manager with other duties.
5.2.2.4 資質要求Qualification Requirements
a. 藥學、化學相關專業(yè)本科及以上；
a. Bachelor’s degree or higher in Pharmacy, Chemistry, or related fields;
b. 熟悉中國GMP、FDA cGMP，EU GMP，ICH Q7，中國藥典，等法規(guī)和標準對質量控制實驗室的要求。
b. Familiarity with Chinese GMP, FDA cGMP, EU GMP, ICH Q7, Chinese Pharmacopoeia, and other regulations and standards relevant to quality control laboratories;
c. 3年以上質量控制相關工作經(jīng)驗。
c. Minimum of 3 years of experience in quality control;
d. 精通HPLC、GC、IR、UV等常用分析儀器的使用、維護及維修。
d. Proficiency in the use, maintenance, and repair of common analytical instruments such as HPLC, GC, IR, UV, etc.