职位描述
Responsibilities:
Implement GMP compliance against global GMP standards and China GMP requirement
根据总部和中国GMP要求，完善GPM的实施工作
· By assisting P&C lab. Manager to conduct GMP Self- Inspection, and follow-up the implementation action to maintain the global level of GMP compliance.
协助理化实验室经理实施GMP自查，跟踪改进实施计划，维护全球性的GMP实施水平
· By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory.
通过维护质量体系和文件系统，确保质量控制部的质量运作体系符合法规要求
Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.
实施样品分发和检验过程的管理职责，保证检验报告及时放行，以支持业务需要。
· By managing working schedule of relative section, to optimize utilization of human resources.
管理相关领域的工作计划，优化人员使用效率
· By monitoring the analysis process to push the analytical report issued in reasonable lead time.
监控分析过程，督促下属在合理的分析周期内签发分析报告
· By monitoring the timely calibration and maintenance of instrument within working section, ensure keeping in good order.
监控工作领域内仪器的按时维护、校验和保养状况，以保证仪器设备的正常使用。
· By monitoring the timely logged, complement of reagents, vessel, reference standard substances, etc. in working section, and ensure sufficient supply.
监控工作领域内试剂、器皿、标准品等的登录和补充状况，以保证正常足量供应。
Tutor subordinators to fulfill analysis tasks.
指导下属完成分析任务。
· By providing technical support to subordinators if necessary share knowledge and experience within working section.
需要时向下属提供技术支持，分享工作领域内的知识和经验。
Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time.
完成分配的日常检验样品，在合理的分析周期内签发正确的分析报告。
· By master analytical methods within working section, comply with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.
熟练掌握工作领域内的分析方法，遵守职业道德和操守，确保分析数据的可靠性和完整性，具备良好的工作适应能力。
· By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.
通过工作时间的合理分配，优化待分析样品的组合，保持合理的 分析周期。
· By form a good working habit to standardize experimental operations.
养成良好的工作习惯，规范实验操作。
· By checking analysis result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.
通过认真仔细地复核分析记录，尽量减少差错，保证数据的准确性和可靠性。
Implement the maintenance and calibration of assigned instruments
实施分管仪器的维护、校验和保养工作。
· By accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.
完成指定仪器的维护、校验和保养工作，确保仪器设备随时满足分析需要。
· By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.
保管相应文件，以便追溯仪器的维护、校验和保养历史以及所有变更
· By keeping contact with instrument company to obtain the sufficient application technical support.
保持与仪器公司联系，以及时获得足够的仪器应用的技术支持。
· By keeping contact with instrument company to obtain the repair service in time.
保持与仪器公司联系，以及时获得及时的维修服务
Implement the analysis method validation.
实施分析方法验证
· By initiate the defined analysis method validation via planning, executing and reporting process.
通过计划、实施和报告阶段启动指定的分析方法验证工作。
· By organizing the resources to complete yearly method validation plan.
通过组织资源、完成年度方法验证计划。
Qualification:
Bachelor of Science Degree or above 理学士及以上学位
Pharmacy, Chemistry, Biochemistry and equivalent 药学、化学、生物化学及相关学科
At least 4 years’ experience in Quality Control of major or joint venture Pharma Company.
至少4年在大型或合资制药企业质量控制工作经验
Language skills – English & Chinese 语言能力-英语及国语
