OQA Sr. Specialist-天津
葛兰素史克全球生产及供应(中国)
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-03-04
- 工作地点:天津
- 招聘人数:若干
- 工作经验:二年以上
- 学历要求:大专
- 职位类别:销售经理
职位描述
Role Purpose 职位目标:1. Deal with change control issues of Products and maintenance the database.
2. Deal with customer complains of product and maintenance the database.
3. Deal with the quality deviations and return goods of product and maintenance the database as OQA DA/IN investigation responsible person.
4. Deal with reprocess/rework/repack and return of product.
5. Monitor in-process control of products’ validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.
6. Support BNRFT project, conduct on-line batch record filling check, to improve right first time rate for BR filling.
7. Document: Prepare, review and train related SOP and batch record.
8. BPCS system: change finished product status and do double check on BOM & API system input.
9. Training the operator, involve qualifying the operator. Have good training skill.
10. Follow up CAPA of complaint and deviation.
11. Perform regular GMP inspection of products as per plan.
Qualifications/Requirements: 申请资格 / 职位要求:
1.? University graduate or higher in appropriate field.
? Minimum 2 -3 years experience in pharmaceutical manufacturing
? Excellent written and oral communication skills.
? Experience in independent working environment.
? Knowledge on GMP & Quality System.
? SDA Licensed Pharmacist
? Excellent interpersonal and networking skills to establish wide range of contacts across groups.
? Demonstrated initiative and analytical problem solving skill.
? Able to influence at all levels.
? Project management skills.
? Hands on with computers for routine work.
2. Deal with customer complains of product and maintenance the database.
3. Deal with the quality deviations and return goods of product and maintenance the database as OQA DA/IN investigation responsible person.
4. Deal with reprocess/rework/repack and return of product.
5. Monitor in-process control of products’ validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.
6. Support BNRFT project, conduct on-line batch record filling check, to improve right first time rate for BR filling.
7. Document: Prepare, review and train related SOP and batch record.
8. BPCS system: change finished product status and do double check on BOM & API system input.
9. Training the operator, involve qualifying the operator. Have good training skill.
10. Follow up CAPA of complaint and deviation.
11. Perform regular GMP inspection of products as per plan.
Qualifications/Requirements: 申请资格 / 职位要求:
1.? University graduate or higher in appropriate field.
? Minimum 2 -3 years experience in pharmaceutical manufacturing
? Excellent written and oral communication skills.
? Experience in independent working environment.
? Knowledge on GMP & Quality System.
? SDA Licensed Pharmacist
? Excellent interpersonal and networking skills to establish wide range of contacts across groups.
? Demonstrated initiative and analytical problem solving skill.
? Able to influence at all levels.
? Project management skills.
? Hands on with computers for routine work.
公司介绍
葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地,该项目注册资金为1亿3千5百万美元,是葛兰素史克集团目前在华投资最大的项目,同时也是目前国内最大规模的外商投资制药企业。
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:苏州工业园区苏虹西路40号
- 邮政编码:215021