QC主管
Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-05-14
- 工作地点：北京-昌平区
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 职位类别：药品生产/质量管理 质量管理/测试主管(QA/QC主管)
职位描述
1. Demonstrated QC experience in lab. Evaluate and troubleshoot routine and non-routine lab technical problems.
2. Mentor, coach and train lab personnel, to ensure that the required initial and continuing training of lab personnel is carried out and adapted according to need.
3. Coordinate with other departments to plan routine lab testing and other testing activities (e.g. stability, investigations)and satisfy the customer service levels.
4. Participation in establishment, implementation and maintenance of the quality system in lab, and to strengthen lab quality systems and processes continually. Demonstrate behaviors and positive attitudes in line with Quality Control values.
5. Implement OOS, Deviation investigation completely and join in Stability Committee.
6. Prepare documents which related to QC lab. Such as SOPs, FRMs and so on.
7. As the delegation of QC team lead, to approve or reject analytical results for bulk product in relation with their specification
8. Carry out the necessary and relevant tests (Process validation testing, Special testing & Compliance testing).
9. To establish, validate and implement QC procedures in lab (e.g. specifications, test methods and other QC procedures)
10. To participate in the investigation of complaints related to the quality of the product,
11. To support the maintenance /qualification /calibration of control instrument in lab are carried out.
12. Evaluate, maintain, store and use the reference standards in lab according to current SOP.
13. To implement QC operations in accordance with written procedures and in compliance.
14. Participation in validation program and perform the corresponding testing.
15. Participation the regular internal audits or self -inspections.
16. Participation in external audit if necessary (contract lab);
17. Follow health & safety procedures. i,e. near miss accidents, workstation assessment etc. provide support to our HS&E department.
18. Represent PharmOps to take Paperless Lab project, coordinate with other PharmOps sites to facilitate this project.
2. Mentor, coach and train lab personnel, to ensure that the required initial and continuing training of lab personnel is carried out and adapted according to need.
3. Coordinate with other departments to plan routine lab testing and other testing activities (e.g. stability, investigations)and satisfy the customer service levels.
4. Participation in establishment, implementation and maintenance of the quality system in lab, and to strengthen lab quality systems and processes continually. Demonstrate behaviors and positive attitudes in line with Quality Control values.
5. Implement OOS, Deviation investigation completely and join in Stability Committee.
6. Prepare documents which related to QC lab. Such as SOPs, FRMs and so on.
7. As the delegation of QC team lead, to approve or reject analytical results for bulk product in relation with their specification
8. Carry out the necessary and relevant tests (Process validation testing, Special testing & Compliance testing).
9. To establish, validate and implement QC procedures in lab (e.g. specifications, test methods and other QC procedures)
10. To participate in the investigation of complaints related to the quality of the product,
11. To support the maintenance /qualification /calibration of control instrument in lab are carried out.
12. Evaluate, maintain, store and use the reference standards in lab according to current SOP.
13. To implement QC operations in accordance with written procedures and in compliance.
14. Participation in validation program and perform the corresponding testing.
15. Participation the regular internal audits or self -inspections.
16. Participation in external audit if necessary (contract lab);
17. Follow health & safety procedures. i,e. near miss accidents, workstation assessment etc. provide support to our HS&E department.
18. Represent PharmOps to take Paperless Lab project, coordinate with other PharmOps sites to facilitate this project.
公司介绍
Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘
联系方式
- Email：chen.li@novartis.com