东莞招聘

职位描述：
工作职责

1. Review of batch records for cGMP compliance

2. Set-up activities to facilitate efficient working and effective partnerships with external groups

3. Communicates with Packaging/ Warehousing personnel and coordinates timely verification of shipping orders

4. Recognizes problems or delays and takes action to prevent or address issues

5. Provides expertise and resolves issues

6. Ensure local IMP release and control process is in line with relevant global SOPs. And implement local IMP release and control process relevant SOP development, if needed.

7. Conduct regulatory required documents review prior to IMP release to country and sites, and during the study when any regulatory required documents changed/amended

8. In charge of authorizing IMP technical release

9. Support audit and inspection in the area of IMP management of clinical development activities. Determine root causes and develop corrective and preventive actions (CAPA) and follow up till CAPA implemented on all major and critical audit findings

10. In cooperation with other QA Units to ensure analysis, assessment and resolution (including CAPAs where indicated) of issues in common interfaces

11. Participate in PH Dev QA investigation activities, as appropriate

12. Provide support to CPO clinical study operation in GMP compliance related activities



岗位要求

1. Min. 5 years experience in the pharmaceutical industry in a relevant field such as compliance, quality assurance, clinical development or a directly related area

2. knowledge and experience of product release or data release preferred

3. Ability to negotiate and communicate

4. Good knowledge of GCP and/or GMP

5.Good knowledge of drug development

工作地点：浦东新区张江科技园 举报 分享

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