QC主管（AOC常规测试）(J25405)

 建立、优化和维护AOC常规测试工作相关操作程序，包括但不限于HPLC, GC, icIEF，rCE-SDS，nrCE-SDS，SEC-MALS，HRMS等方法验证和检测，使其符合cGMP法规要求。

Establish, optimize, and maintain operating procedures related to AOC routine testing, including but not limited to method validation and testing for HPLC, GC, icIEF, rCE-SDS, nrCE-SDS, SEC-MALS, HRMS, etc., ensuring compliance with cGMP regulations.

 参与偏差调查、变更、客户质量投诉调查，确保纠正和预防措施的有效执行和记录。

Participate in deviation investigation, change control and customer complaint investigation, ensure the effective execution and record of corrective and preventive actions.

 发起或审核质量相关的变更。

Initiate or review quality-related changes.

 负责/参与AOC相关原料、中间品、产品的取样和测试的管理。

Responsible/participate in the management of sampling and testing of AOC related raw materials, intermediate products and products.

 负责/参与稳定性考察和研究管理

Responsible/participated in the stability monitoring and study management.

 项目跟踪和客户质量协议的执行，传达内部知晓，满足客户期望

Project follow-up and Quality Agreement execution. Share information internally and meet customer expectations.

 跟踪项目进程，协调各类测试资源，解决项目测试过程中发现的问题，保证各项分析工作的顺利开展。

Follow up the project progress, coordinate various testing resources, solve problems found during the project testing process, and ensure the smooth progress of all analysis work.

 负责/参与实验室试剂、溶液和滴定液的管理

Responsible/Participate in the management of lab reagents, solutions and volumetric solutions

 负责/参与对照品管理与控制

Responsible/participate for the management and control of reference standard.

 负责/参与留样与保存的管理

Responsible/Participate in the management of sample retention and storage

 负责/参与审核方法确认/验证/转移文件

Responsible/Participate in the review of Method verification/Method validation/transfer documentation.

 负责/参与方法和规格的管理

Responsible/Participate in the management of method and specification.

 负责/参与质量标准管理

Responsible/Participate in the management of quality standard

 监督执行实验室事件、偏差调查和OOX结果的实验室调查

Oversight the execution of lab investigations of lab events，deviations, and OOX results.

 监督执行分析原始数据的审核、相关测试报告和CoA的出具与审核。

Oversight the execution the review of analytical raw data, issuance and review of relevant test reports and CoA.

 监督/管理实验室仪器、设备，保证其持续稳定可靠，满足分析需求并提供准确可靠的数据。

Oversight /management laboratory instruments and equipment to ensure their continuous stability and reliability, meet the requirements and provide accurate and reliable data.

 审核QC相关验证主计划及确认方案、报告以及校验文件

Review and approve the master plan, qualification protocol, report and calibration for QC

 监督/执行计算机化系统验证和管理、访问控制，定期回顾

Oversight the execution of computerized system validation and management, access control, periodical review

 QC电子数据的管理和维护

Management and maintenance of QC electronic data.

 监督执行数据完整性要求，潜在的数据完整性问题得到调查和评估。

Oversight the execution of data integrity requirements, and potential data integrity issues are investigated and evaluated.

 内部/客户/官方审计接待和审计回复，相关CAPA的跟踪、执行。

Handle regulatory/internal/client audits and audit responses, and CAPA tracking and implementation.

 持续改进实验室现场管理，保持环境整洁安全，协调资源, 确保日常运行符合cGMP /EHS规范要求。

Continuously improve site management, keep the environment clean and safe, coordinate resources, and ensure that daily operations comply with cGMP/EHS requirements

 人员培训和资格认定

Personnel training and qualification

 IP和安全操作

IP and security operations

 完成上级主管安排的其他工作和任务。

Jobs and responsibilities assigned by the supervisor.

药学或生物等相关专业，本科及以上学历

了解制药生产、ADC/AOC/抗体等生物大分子、检测和质量管理，熟悉GMP相关法规

良好的英文读写能力

三年以上AOC/ADC/生物大分子的实验室工作经验，一年以上管理经验