职责Responsibilities：
a. 在QC经理的指导下，负责配样室、仪器室、液相室、气相室、理化实验室及稳定性实验室的维护管理；
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. 负责指导液相QC、气相QC、理化QC等人员的日常工作，进行绩效考核和评价；
b. Guide the daily work of HPLC QC, GC QC, and physicochemical QC staff, conducting performance evaluations;
c. 负责分析仪器的使用、维护、确认及期间核查的培训工作；
c. Conduct training on the use, maintenance, qualification, and periodic verification of analytical instruments;
d. 负责检查质量控制部分析仪器的日常管理和运行，确保仪器正常运行并符合文件和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. 负责指导部门仪器的定期维护、维修、验证、确认及期间核查、校准等工作；
e. Guide regular maintenance, repair, validation, qualification, periodic verification, and calibration of departmental instruments;
f. 作为QC部门文件管理员协助QC经理进行部门档案管理工作；
f. Serve as a document administrator for the QC department, assisting the QC Manager in managing departmental records;
g. 负责进行QC实验室运行的日常监督、检查工作；
g. Oversee the daily supervision and inspection of QC laboratory operations;
h. 复核分析方法转移/确认/验证方案及报告，带领QC人员完成分析方法转移/确认/验证并进行记录复核；
h. Review analysis method transfer/validation protocols and reports, leading QC staff in executing method transfers/validations and reviewing records;
i. 指导QC人员完成产品相关原辅料、包装材料的放行检测并进行记录和COA复核。
i. Guide QC staff in performing release testing for raw materials, packaging materials, and intermediates, reviewing records and Certificates of Analysis (COAs);
j. 指导QC人员完成分析方法开发、验证工作，审核开发报告、验证方案和报告。
j. Guide QC staff in developing and validating analysis methods, reviewing development reports, validation protocols, and reports;
k. 指导QC人员完成产品相关反应监控、中间体、原料药检测并进行记录复核和COA；
k. Guide QC staff in monitoring reactions, testing intermediates and APIs, and reviewing records and COAs;
l. 复核稳定性试验方案，带领QC人员完成稳定性试验并进行记录及报告复核；
l. Review stability study protocols, lead QC staff in completing stability studies, and review records and reports;
m. 负责参与制定原辅料、中间体、包装材料质量标准和检验方法操作规程及检验记录；
m. Participate in establishing quality standards and SOPs for raw materials, intermediates, and packaging materials, as well as inspection records;
n. 复核原辅料、中间体、包装材料质量标准和检验方法操作规程及检验记录；
n. Review quality standards and SOPs for raw materials, intermediates, and packaging materials, as well as inspection records;
o. 参与和支持生产工艺验证，清洁验证工作；
o. Participate in and support process validation and cleaning validation activities;
p. 协助QC经理完成其他事务。
p. Assist the QC Manager with other duties.
5.2.2.4 资质要求Qualification Requirements
a. 药学、化学相关专业本科及以上；
a. Bachelor’s degree or higher in Pharmacy, Chemistry, or related fields;
b. 熟悉中国GMP、FDA cGMP，EU GMP，ICH Q7，中国药典，等法规和标准对质量控制实验室的要求。
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年以上质量控制相关工作经验。
c. Minimum of 3 years of experience in quality control;
d. 精通HPLC、GC、IR、UV等常用分析仪器的使用、维护及维修。
d. Proficiency in the use, maintenance, and repair of common analytical instruments such as HPLC, GC, IR, UV, etc.