深圳招聘

KEY ACCOUNTABILITIES
关键职责
1. Know the current regulation to be applied and keep updated level of knowledge.
清楚当前应用的规范，并不断提高知识水平。

2. Quality routine activities on longgang site and Quality documentation management:
质量部日常工作以及文档管理：
a.routine activities , e.g. FI, CCR, inspection on site, to make sure that systems and quality activities are compliant with requirement of SOP, CQR.
日常活动，如偏差调查，变更控制，现场巡查等，确保系统和质量活动，符合SOP和CQR的要求
b.Prepare and/or review the SOPs, protocol, report, VMP, VMP concerning qualification, validation, calibration.
起草和/或审核与确认、验证、校验有关的标准操作程序、草案、报告、验证主计划以及报告。

3. Contribution to all validation execution， including new project, annual re-qualification and re-calibration:
参与公司年度再校验和再确认的活动，以及新项目的验证活动。

4. ensure the routine quality activities on site, follow the change control and FI， for HVAC system and water system specially
确保工厂质量保证正常运行。跟踪解决日常活动中发生的变更和偏差, 尤其是空调系统和水处理系统等。

5. special training, f.g. validation, computerized system， documentation control etc.
举行专题培训，例如验证，计算机系统，文件控制。

6. Management of QC sampling room in blending building， improvement and monitoring of warehouse.
QC取样室的管理和运行，仓库的日常监控和改进.

REQUIREMENTS
任职资格
- Chinese with University qualification or above;
本科或以上
- Pharmaceutical and /or biological background, validation knowledge and activities know
how is necessary;
药学或生物学背景，具有验证经验
- Engineering background is a plus;
具有工程背景
- More than 12 years of related experience in pharmaceutical industry;
在制药工业有12年以上相关经验
- More than 5 years in a similar position;
有5年以上的类似岗位经验
- Prior experience in a MNC is a plus;
有跨国企业工作经验优先
- Other experiences within a quality organization (such as quality systems and quality control) desirable;
具有在质量组织内(如质量系统和质量控制)的其他经验为佳
- China GMP strong knowledge along with change control and CAPA processes
扎实的中国GMP知识、变更控制和CAPA流程知识
- Strong quality & safety culture
深厚的质量安全文化
- Problem solving, teamwork and leadership skills
具有解决问题，团队合作及领导能力
- Continuous improvement mindset (Lean manufacturing prior experience is a plus)
具有不断进步改善的心态（精益生产经验者优先）
- Computer skill: word, excel at least;
熟练使用word和excel
- English: Oral, read and writing skill is required, simple communication of French is
advantage.
良好的英语能力，会法语优先;

深圳赛诺菲巴斯德生物制品有限公司诚聘