1. Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）

Implement calibration within the assigned categories and maintain calibration data including Calibration Master List to ensure calibration execution in SRPL compliance with relevant company policies, headquarter guidelines and regulatory guidelines.

实施指定类别的计量器具校准，维护校准数据，包括校准主清单，确保校准执行活动符合有关公司政策、总部规范和法规要求。

1. Support Other Colleagues within the team: Support other colleagues within calibration team as required.

支持团队其他同事：根据需要支持团队内其他同事的工作。

2. Maintain Calibration SOP/National Standard: Maintain calibration SOPs to ensure that calibration activities in SRPL compliance with relevant company policies, headquarter guidelines and regulatory guidelines. Follow up the National Standards updating and ensure that the calibration work of the company meets the requirement of the regulations.

维护校准SOP/国家规程：维护校准SOP以确保上海罗氏的校准执行活动符合有关公司政策、总部规范和法规要求。及时掌握国内计量法规的要求与变化，并确保本公司计量工作符合法规要求。

3. Calibration Master List: Maintain and update Calibration Master List on daily basis according to criticality assessment form and calibration execution.

校准主清单：根据校准关键性评估表和校准实施情况每日维护更新校准主清单。

4. Support Calibration SOPs from other department: Provide technical support for calibration SOPs from other department to ensure that calibration activities in SRPL compliance with relevant company policies, headquarter guidelines and regulatory guidelines.

对其他部门的校准SOP给予技术支持：对其他部门的校准SOP给予技术支持以确保上海罗氏的校准执行活动符合有关公司政策、总部规范和法规要求。

5. Support CAT: Prepare calibration plans and reports. Involve calibration deviation. Provide other support to CAT as required.

支持关键性评估团队的工作：准备校准计划与报告。参与校准偏差。根据需要提供其他CAT的支持工作。

6. Calibration Execution Internal and External within assigned categories: Implement calibration for measuring instruments within assigned categories in time according to calibration plan. Contact with the Third Party in time to ensure that all the measuring/reference instrument within assigned categories calibrated in time according to calibration plan.

内部和外部指定类别的校准实施：根据校准计划完成指定类别的计量器具校准。根据校准计划及时与校准第三方联系, 确保指定类别的计量器具/标准器按时完成校准。

7. Calibration Certificate: Prepare and check calibration certificate.

校准证书 ：准备和复核校准证书。

8. Calibration documentation: Archive calibration related documentation.

校准文件：整理归档校准相关文件。

9. Particle Monitoring for GMP Clean Area: Implement particle monitoring in GMP area in time and with high quality. Implement recovery test in GMP area in time and with high quality.

GMP环境的空气粒子监控：按时按质完成GMP区域的空气粒子监控。按时按质完成GMP区域的恢复性测试。

10. Illuminance Test for GMP Clean Area: Implement illuminance test in GMP area in time and with high quality.

GMP环境的照度测试: 按时按质完成GMP区域的照度测试。

11. Monitoring and Testing Document: Prepare related document in time and with high quality.

监控和测试文件按时按质完成相关的文件。

1. Qualification and Experience 能力与经验

• Education/Qualifications教育程度/所获资格证书
• Bachelor
• 学士学位
• Leadership Competencies领导者胜任力
• N/A
• Job Required Competencies岗位所需胜任力
• 3 years in pharmaceutical company, 2 years’ experience of calibration or Environment monitoring in pharmaceutical company
• 3年药厂工作年限，2年药厂校准或环境测试经验
• Knowledge of GMP, Knowledge of Quality management
• GMP知识，质量管理知识
• Professional knowledge of quality assurance, quality control or pharmacy production
• 质量保证，质量控制或制药生产专业知识
• Language skill: Good at English, listening, speaking, reading and writing.
• 语言技能: 具有良好的英语听说读写能力
• PC skill: Skilled word, excel, mail editing ability
• 电脑技能: 熟练的文档，表格和邮件编辑能力。

上班地址：龙东大道