天津招聘

职位描述：

1、Job responsibilities (Select the corresponding items based on the work actually responsible for)/工作职责（根据实际负责的工作选择相应的）：

1) As implement manager of the validation/qualification manager, organize the validation team to fulfill the responsibilities in the facility/utility/equipment qualification.

作为质量保证活动的基层管理者，组织、协调和带领厂房/设施/设备的验证小组履行验证工作中的各项职责；

2) Organize the qualification work in all sites, and provide the necessary support and guidance, and work personally in each sites when necessary.

组织和协调凯莱英各厂区的验证工作，为各厂区各部门在工作执行中给于必要的指导，工作必须时需要亲临各厂区工作；

3) Organize and supervise the drafting of URS, responsible for review and approval.

组织监督督促各使用部门对于URS的撰写，并履行审核批转的义务；

4) Provide compliance consulting and support to the equipment use department and engineering department during the facility/utility/equipment design.

向各使用单位以及设备部提供厂房/设施/设备设计中的合规性咨询，并协助不但完善提高；

5) Discuss and approve the proper qualification plan, and ensure the on time implementation.

与使用部门以及设备部讨论验证计划，制定合理的验证计划，确保验证工作按计划执行；

6) Review and approve all P&ID diagram, responsible for the archiving.

P&ID的登记归档管理；

7) Organize the drafting of qualification protocol, review and approval. Take part in the implementation, and provide some guidance and support.

组织验证方案的撰写，审核，审批，在执行过程中实际参与，并给于指导；

8) Take part in the problem solving, help to work out the proper CAPA, review and approve the change and deviation in the validation/qualification.

参与执行过程中问题的解决，协助制定整改措施；复核并审批验证过程中产生的各类偏差变更文件。

9) Organize and approve the validation report, ensure the record and data integrity, closeout before put into use, and finally archived.

组织撰写并批准验证报告，并确保数据以及记录的完整性，在厂房/设施/设备使用前得到及时关闭，并登记归档。

10) Organize the work skill trainings and testing on the facility/utility/equipment qualification. Help the employ to improve their skills, continuously improve Asymchem’s validation/qualification skill.

定期组织相关的厂房/设施/设备验证的业务培训和考核，督促员工积极提高业务能力和cGMP专业知识，不断提供公司的验证水平。

11) Take active part in the CAPA plan during the audit, correct and improve.

积极制定对于各种审计中对于厂房/设施/设备验证中的观察项的整改措施，并组织整改提高。

12) Perform the qualification review on the facility/utility/equipment according to Asymchem’s qualification procedure, ensure all the facility/utility/equipment are in good state.

按照公司内部的质量体系要求，定期对于厂房/设施/设备验证进行回顾，确保各厂房/设施/设备验证处于正常运转之中。

13) Optimize the validation/qualification work flow to improve the work efficiency.

优化公司的验证管理流程以及提高整体验证工作效率；

14) Collect the typical example and provide case study to the team during the scheduled meeting.

收集和总结业务工作相关的典型问题，在相关部门会议或专门会议中予以普及性讲解与强调。

15）Be responsible for other tasks assigned by the superior.

负责其他上级管理人员安排的相关工作。

2、Personnel Management/人员管理职责：

1) Responsible for the work performance assessment to the qualification team, dismiss or promote.

负责验证团队人员的工作评价奖金评定、不合格人员的辞退提议和优秀人才的提任提议等。

2) Ensure the effective communication within the team, and the Asymchem’s requirement is well passed and followed in the ream.

保证验证团队内部的有效沟通，同时确保公司内各项制度、政策部门内有效的传达和贯彻执行。

3) Responsible for the qualification work assignment to the team, and help to improve work skill to the QA team, keep the team stable.

负责对验证团队工作进行合理分配和调整，并协助QA管理层推行本部门内的梯队人员培养、员工关怀以确保人才的稳定性。

4) Responsible for work supervise, and provide guidance to the team, ensure the overall communication efficiency.

负责监督、指导部门内下属员工的工作，对下属员工开展必要的沟通指导和监督，确保整体沟通的质量和效率。

5) Responsible to answer the questions from the team, and provide feasible suggestions, if beyond, feedback to the upper leader.

负责对下属员工提出的解决不了的合理的意见与建议进行有针对性的帮助，若确属自己也解决不了的，须及时向上级领导反馈。

6) Keep Asymchem image in mind, stop and lead the employee from the improper actions which is not good for Asymchem image.

负责维护公司形象，对于部门内有影响公司形象、影响部门人员团结的言论与行为需要加以制止和引导。

3、Safety Responsibilities/ 安全职责：

1) Follow and supervise the team members to follow Asymchem’s safety management requirement.

遵守并监督下属员工遵守公司的安全管理规定。

2) Actively learn and prevent the emergency incident, know the positions of the fire fighters and correctly use it, safety exit.

主动学习防范突发事故的能力：了解消防器材的摆放位置，熟悉公司环境，熟知安全出口的位置，能够熟练操作灭火器等。

3) Learn Asymchem’s safety case study notification, plan some preventive actions to the safety issues.

学习公司的安全简报、奖惩通告，做好安全隐患的防范和预防。

4) With the right and obligation to propose correction on the potential risk and hazard of safety.

对于公司内存在的安全隐患有提出整改的权利和义务。

5) Execute and close the responsible CAPAs on potential risk and hazard of safety as found during the hazards screening.

对于公司安全排查发现的安全隐患事项，须按照CAPAs的要求，对于自己负责的工作按期完成整改。

6) Participate and supervise the subordinates to participate the safety training organize within the department and company.

参加并监督下属员工部门或公司组织的安全管理培训。

任职要求：

1）统招本科以上学历，4年以上工作经验。

2）英语水平良好，能用英语汇报工作。

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