岗位要求 Job Requirement:

- 本科及以上学历，药学相关专业
Bachelor degree or above with pharmaceutical related major.
- 熟悉实验室检验方法、流程、样品管理和实验室设备
Be familiar with chemical test procedures, test practice, samples management and lab equipments.
- 能熟练使用电脑，英语口语流利
Good skills on computer systems and oral English.
- 具备出众的学习能力和积极的工作态度
Eager to learn and have a positive attitude on job.

岗位职责 Job Responsibility；

- 在期望的时间内根据现行的TP来进行原材料、中间产品和成品的检验。根据相关药典的变更，对现行方法进行评估，完成方法验证。
To perform raw materials, in-process and finished products assay according to current TP within the desired lead time. To perform method evaluation according to related pharmacopoeia changes. And complete method verification or validation if appropriate.
- 根据规程的要求，对微生物检验设备和仪器进行校正保养和维修保养，并配合完成相关的设备验证工作。
To perform the equipment calibrations and maintenance in micro lab according to the procedures on a preplanned schedule.
- 负责实验室的菌种，生物指示剂，培养基及试剂试液的管理和使用，保证其在有效期内使用。
Responsible for lab test strains, BI, culture media, Test reagent/solution management and use, keep all materials to be used within their shelf life.
- 支持相关的工艺验证，及时完成相关的化学微生物检测活动，并出具报告。
Support related process validation, and complete microbial tests requested and report on time.
- 审核和实施清洁验证方案。
To review and implement cleaning validation protocols.
- 负责环境监测，纯水和其他GMP公用工程设施的监测。
To be in charge of environmental, purified water system and other GMP utility monitoring.
- 及时完成与工作相关的培训及资质认定，保证检验的顺利进行。
Implement related training and qualification program timely and complete tests smoothly.
- 通过日常的清洁和良好的保养工作，维护实验室清洁、安全的环境，操作过程中严格遵守公司HSE的相关规定，避免伤害事故的发生。
To maintain lab in clean and safe condition by routinely cleaning and good housekeeping. Must follow up HSE related requirement when performing testing to avoid accident happened.
- 根据GMP 和GLP要求, 有序/有组织地书写分析报告和其它文件。
To write the analytical reports and other documents in order and organized format to comply with GMP and GLP.
- 做其他与质量相关的事项。
To assume other tasks related to Quality.