Shanghai Novartis Trade Warehouse QA (SNT WH QA)
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:2013-07-11
- 工作地点:上海-浦东新区
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:药品生产/质量管理 仓库管理员
职位描述
DUTIES AND RESPONSIBILITIES
1. Be responsible for imported finish product release to market (review of Certificates of Analysis and Care Check for imported finished products), monitor repackaging and samples operation after stamping as the delegation of QA authorization
2. Ensure the based field recall procedure to comply with Novartis Quality Module and China cGMP/GSP requirements. Cooperate the Recall system challenge test annually, to make sure that Novartis Recall system is sensitive and effective according to relevant SOPs
3. Access and availability of know-how in respect to “state of the art” GMP/GSP know-how and future trends in the fields of GMP, GSP, etc.
4. Ensure the Handling of the returned goods is timely; meet the related SOP’s and cGMP’s /GSP’s requirements.
5. Ensure the operation comply with cGMP, GSP
6. Maintain cross-contacts with other sections/country for Counterfeit Handling
7. Provide effective compliance supporting and services to the other functions
8. Participate internal and external audits
9. Attend to any other work related assignment, which may be given by the superior
10. Report issue and deviation on time to the relevant function
11. Provide input for process improvement
12. Comply with Corporate Citizenship Standards
REQUIREMENTS:
1. University Graduate in Pharmacy or Chemistry or related areas
2. 3-5 years experience in the GMP/GSP field in Pharmaceutical industry, JV experience has priority
3. Licensed Pharmacist and whose home based Shanghai is preferred
4. Effective oral and written abilities in English
5. Good at communication
6. Middle level management skill (independent, flexible, and hard working)
7. Have basic knowledge for local GMP/GSP and other regulatory
8. Have basic knowledge for word, excel, power point, ect.
9. Contract with Sandoz in Shanghai and long-term based in WaiGaoQiao WH
1. Be responsible for imported finish product release to market (review of Certificates of Analysis and Care Check for imported finished products), monitor repackaging and samples operation after stamping as the delegation of QA authorization
2. Ensure the based field recall procedure to comply with Novartis Quality Module and China cGMP/GSP requirements. Cooperate the Recall system challenge test annually, to make sure that Novartis Recall system is sensitive and effective according to relevant SOPs
3. Access and availability of know-how in respect to “state of the art” GMP/GSP know-how and future trends in the fields of GMP, GSP, etc.
4. Ensure the Handling of the returned goods is timely; meet the related SOP’s and cGMP’s /GSP’s requirements.
5. Ensure the operation comply with cGMP, GSP
6. Maintain cross-contacts with other sections/country for Counterfeit Handling
7. Provide effective compliance supporting and services to the other functions
8. Participate internal and external audits
9. Attend to any other work related assignment, which may be given by the superior
10. Report issue and deviation on time to the relevant function
11. Provide input for process improvement
12. Comply with Corporate Citizenship Standards
REQUIREMENTS:
1. University Graduate in Pharmacy or Chemistry or related areas
2. 3-5 years experience in the GMP/GSP field in Pharmaceutical industry, JV experience has priority
3. Licensed Pharmacist and whose home based Shanghai is preferred
4. Effective oral and written abilities in English
5. Good at communication
6. Middle level management skill (independent, flexible, and hard working)
7. Have basic knowledge for local GMP/GSP and other regulatory
8. Have basic knowledge for word, excel, power point, ect.
9. Contract with Sandoz in Shanghai and long-term based in WaiGaoQiao WH
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