岗位描述
岗位职责:
1、负责CU系统(SW/PW/WFI/PS/PA/N2/O2/CO2)的运行和维护。
Responsible for operation and maintenance of CU system (SW/PW/WFI/PS/PA/N2/O2/CO2) in HBST.
2、 负责起草或修订SOP,并对设备或系统进行培训。
Be responsible for drafting or revising SOPs and training for equipment or systems.
3、配合内部审计、客户审计和外部审计。配合客户完成审核工作,回答客户对CU系统的疑问。
Cooperate with internal audit, customer audit and external audit.
Cooperate with customer to complete audit work, answer customer's questions about CU system.
4、参与技术技能方面的持续改进工作,如精益改善项目,以优化流程,提高效率,减少浪费和缺陷。
Participate in continuous improvement work in terms of technical skills, such as LEAN projects to optimize processes, to improve efficiency, reduce waste and defects.
5、确保所有活动符合cGMP和公司质量、合规性、EHS等。
Ensure all activities are compliant with cGMP and corporate quality, compliance, EHS etc.
6、负责指定设备的升级、改造和扩建。
Responsible for the upgrading, renovation and expansion of designated equipment.
任职要求:
Bachelor degree or above / 10+ years of work experience
本科以上学历/10+年工作经验
Pharmaceutical, engineering, mechanical related majors
制药、工程、机械相关专业
Good English listening, speaking, reading and writing skills;
具备良好的英语听说读写能力;
Proficient in using office software;
熟练使用办公软件;
Good communication and coordination skills.
良好的沟通和协调能力。
Familiar with relevant regulations and industry standards; familiar with pharmaceutical process and related equipment knowledge
熟悉相关法规和行业标准;熟悉制药工艺及相关设备知识