Job Description
1. Perform routine physical chemistry testing, e.g. particle analysis, tensile strength, extensibility, MVP, absorption, purified water monitoring. If need, execute the relevant test, draft SOP/ protocols/reports and implement method validation and qualification in lab.(30%)
执行常规的理化测试,例如:粒径分析、拉伸强度、舒适性、水蒸气透过性、吸收率、纯化水的监控。需要时,执行相关领域测试,起草SOP/方案/报告和实施方法验证和确认等工作。(30%)
2. Review testing results for compliance to specification and report abnormalities. Assist in the assessment, investigation and resolution of OOS occurrences. Support change controls, project, CAPAs and investigation processes.(30%)
审核测试结果是否符合质量规范以及异常报告。协助评估、调查并解决OOS问题。 负责记录的归档和维护,定期回顾记录并及时销毁过期记录。协助变更控制、项目、CAPA和调查程序(30%)
3. To maintain the lab material purchase system to ensure all materials ready for test in time. Perform required calibration and maintenance on laboratory equipment. Manage the stability sample, retaining sample, consumable and reagent.(10%)
负责协调实验室相关采购并确保测试相关物料的有效供应和及时测试。校验和维护实验室设备。管理稳定性样品、留样、易耗品和试剂(10%)
4.Ensure lab related validation work such as cleaning, expiry date and transit being followed and implemented effectively.(10%)
确保相关实验室验证工作如清洁、有效期和运输等方法得到有效跟踪和实施。(10%)
5.Ensure compliance to QS procedures covering job requirements/procedures/testing etc. Ensure safe working in accordance with cGMP/HSE guidelines at all time(10%)
确保工作要求/程序/测试等符合QS程序。始终按照cGMP /HSE 的要求安全工作(10%)
6.Work as a collaborative team member. Other tasks assigned by the supervisor.(10%)
团队合作,主管分配的其他工作。(10%)
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