QC Specialist(理化 仪器方向）

工作地点：无锡         所属类型：QC         发布时间：2020-07-31

岗位描述：

Job Description

1. 根据cGMP进行分析测试，以支持原材料，过程中，最终产品，稳定性和方法转移测试。

Analytical testing in accordance with cGMP to support raw material, in-process, final product, stability and method transfer testing.

2. 根据制造/质量控制批次记录，稳定性协议等执行各种分析测试程序。

Perform various analytical testing procedures according to manufacturing/quality control batch records, stability protocols, etc.

3. 协助设计方法验证，执行包括方法转移活动在内的验证研究。

Assisted in designing method validation and carried out validation studies including method transfer activities.

4. 审查，分析，解释和报告数据。

Review, analyse, interpret and report data.

5. 与项目经理和质量检查人员合作，以确保及时测试和放行。

Work with Project Managers and Quality Inspectors to ensure timely testing and release.

6. 进行仪器分析，例如Karl Fischer，UV，HPLC，AA和气相色谱等。

Perform instrumental analyses such as Karl Fischer, UV, HPLC，AA and GC.

7. 负责调查事件报告和OOS/OOT结果，在QC / QA团队中管理CAPAs和变更控制程序。

Responsible for investigating incident reports and OOS/OOT results, and managing CAPAs and change control procedures within QC/QA teams.

8. 参与校准，排除各种类型的设备故障，包括主动解决仪器问题。

Participate in calibration and eliminate various types of equipment faults, including actively solving instrument problems.

9. 创建和维护规范、分析方法、sop和培训材料。

Create and maintain specifications, analytical methods, sops and training materials.

10. 按照标准操作规程执行良好的文档和实验室安全规程。确保质量控制区域符合GMP、SOP或法规和EHS的要求。

Follow good documentation and laboratory safety procedures in accordance with SOPs. Ensure the quality control area complies with GMP, SOP or regulatory and EHS requirements.

11. 改进和维护QC区域内的合规体系。必要时参与内部和外部GMP审核。

Improve and maintain the compliance system in the QC area. Participate in internal and external GMP audits as necessary.

12. 跟踪每个项目的工作时间。

Track the working hours on each project.

13. 参加所需的会议。

Participation in required meetings.

任职资格：

任职条件

一、 学历要求 / Diploma : 药学相关专业，大专以上学历

College degree in Pharmacy or related major.

二、 语言要求 / Language : 英语流利

Fluent in English

三、 工作经验 / Experience :

3年以上GMP环境实验室工作经验;有FDA和cFDA审计经验者优先。

Over 3 years of laboratory work experiences in GMP environment; FDA and cFDA audit experience is preferred.

擅长分析（化学）仪器和方法，如HPLC和GC等,有仪器故障排查经验优先。

Specializes in analytical instruments and methods, such as HPLC and GC；Experience in instrument troubleshooting is preferred

五、 个人品质/Personality

1.具有良好的学习，协调及沟通能力

Fast learning, cooperating, and communicating capability

2.具有良好的抗压能力，数据导向，及灵活性

Pressure tolerance, data orientation, and flexibility