QC主管（AOC常规测试）(J25405)

AI 摘要智能生成

 参与偏差调查、变更、客户质量投诉调查

职位描述

 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.

任职要求

• 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