天津招聘

Job Purpose and Key Responsibilities 岗位的目的和主要岗位职责:
? why job exists / what it must achieve岗位为什么存在 / 岗位必须完成的工作

Job Purpose 岗位目的:
Ensure the quality assurance of responsible product line, check and control the process according to GMP.
Coordinator for investigation of deviation, change control and customer complaint.
Work with Value Stream staff to improve on-line management to mitigate potential quality risk.

Key Responsibilities主要岗位职责:
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.
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.
12. Coordinator and prepare product annual product review.
13. Monitor in-process control for product, review updated batch record.
14. Deal with the OQA related works of new product issues.
15. Perform other jobs assigned by OQA Section Manager.
16. As quality representative of BPCS system.
Accountability 责任:
? primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships
责任范围，对公司战略、政策、业务及人际关系的影响程度
1. Ensure the quality assurance of responsible product line.
2. Ensure no missed market launch dates due to QA section function failures.
3. Be a key person to communicate with sales & marketing on product quality. Take charge of customer feedback and complaint. Co-ordinate the site investigation amongst relevant departments to ensure high quality level and prevent recurrence.
4. Close the customer complains/deviation/change control on time.
Specialised Knowledge 专业知识:
? breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度（跨学科），所需知识的深度 （特定学科）
? 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.

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。