1. 熟悉国家关于环境、安全、健康方面的法律、法规；负责ehs管理体系的建立、完善以及改进，以及体系的贯彻和运行，包括项目建设过程和工厂运行过程；
2. 负责公司安全、环保、消防和职业健康的全面管理，提出工作方案、计划、和预算；
3. 确保公司ehs管理符合法律、法规和公司的ehs方针，完成公司ehs管理目标；
4. 负责事故调查，提出capa方案并贯彻实施；
5. 负责公司ehs风险管理和应急管理，并指导公司各部门贯彻实施；
6. 负责公司定期ehs内外部审计和日常ehs检查；
7. 负责合同承包商的ehs管理；
8. 负责公司各部门和全员的ehs培训和ehs演练；

1. 隶属部门/situation in structure
属qc主管直接领导
directly lead by qc supervisor
2. 职责/mission
根据标准和程序及时准确地对物料、半成品和成品等样品进行化学分析

according to the criteria and procedures for the timely and accurate chemical analyses of materials,semi - finished products and finished products etc
3. 主要工作/main activities
按照质量标准及检验规程完成半成品、成品、物料和稳定性等样品的化学检验
及时并真实记录测试的原始数据与结果，并完成检测报告
及时汇报测试过程中发现的异常与偏差，配合主管进行化学实验室oos调查
及时登记仪器使用记录, 完成所使用仪器的维护与校验, 使其符合gmp要求
严格按照实验室文件的要求进行各项操作, 做好试剂、试液、标准品、易耗品等使用登记
遵守实验室安全制度
完成上级领导安排的其他工作
according to the quality standard and test method to finish the chemical analyses for semi-finished 、products 、materials and stability samples etc
timely and truthfully record the raw data and results of tests and complete analytical reports
timely reporting anomalies and deviations found in the testing process, assist the supervisor to investigate the chemical laboratory oos
registered instrument using records timely, complete the maintenance and calibration of laboratory instruments, to meet the request of gmp
in strict accordance with the lab files required for operation, make a using registration for reagents 、 test solution、reference standard and consumables etc
compliance with laboratory safety policy
finish other tasks assigned by superiors
4. 能力要求/competence
具有药学或相关专业大专及以上学历
2年以上制药企业qc实验室工作经验
熟悉理化分析方法和仪器的操作
责任心，细心
好的沟通、协调能力， 团队精神
很强的学习能力
should have a pharmaceutical or related college degree or above
2 years’ work experience in qc laboratories of pharmaceutical enterprises
familiar with physical-chemical analytical methods and equipment operation 　 　
responsible, carefulness
good communication skill, association ability and team spirit
strong ability of learning

1.隶属部门/situation in structure
属质量保证部/质量保证经理直接领导
directly lead by qa manager

2.职责/mission
负责各项质量保证部门文件管理相关工作。
responsible for qa document management related work.

3.主要工作/main activities
?按照sop的规定，负责sop的建立、审核、回顾、修订、归档、发放、回收和销毁；
?按照sop的规定，负责质量标准及分析方法的建立、审核、回顾、修订、归档、发放、回收和销毁；
?按照sop的规定，开展年度产品回顾的工作；
?按照sop的规定，负责客户要求档案的建立、更新、发放和回收；
?参与质保部开展质量活动；
?参与质保部的日常工作：生产过程的监督，不合格证的发放，物料合格证的发放，包材的检查，产品取样等；
?参与验证的取样；
?其它上级指派的有关质量管理的工作。

?according to the specified sop, take ｃｈａｒge of the establishment, check, review, revision, archivement, issuance, withdraw and destroy of sops;
?according to the specified sop, take ｃｈａｒge of the establishment, check, review, revision, archivement, issuance, withdraw and destroy of specifications and analytical method;
?according to the specified sop, carry out the work of annual product review;
?according to the specified sop, take ｃｈａｒge of the establishment, updating, issuance and withdraw of client request files;
?participate the quality activities of quality assurance dept;
?participate the daily work of quality assurance dept. : supervision of manufacturing process; issuance of rejected labels and material approved labels; check of packaging materials; product sampling etc;
?participate in the sampling required for validation;
?other works related to quality management appointed by superior.

4.能力要求/competence
?具有药学或相关专业大专及以上学历；
?3-5年医药行业工作经验，有qa工作经验者优先；
?英语6级，良好的读写能力；
?熟练使用电脑办公软件。

?should have a pharmaceutical or related college degree or above；
?3-5 years working experience in pharmaceutical industry，qa working experience is a plus；
?english level (cet-6), good at reading and writing；
?good skills at using office software.

5.个性要求/ personality requirement
?性格积极向上，富于团队精神。

?positive attitude，team work spirit.