苏州招聘

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 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.
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.
17.Change Control Management
18.TTS responsibility
19.Review and report Quality KPI from OQA

Specialised Knowledge 专业知识:
?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。