天津招聘

职位描述：
Job Purpose 岗位目的:
1. Ensure the quality assurance of responsible product line, check and control the process according to GMP.
2. Coordinator for investigation of deviation, customer complaint, supplier complaint;
3. 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 Deviation issues of Products and maintenance the database.
2. Deal with customer complains of product and maintenance the database.
3. Deal with supplier complains of product and maintenance the database.
4. Deal with the quality deviations and return goods of product and maintenance the database as OQA DA investigation responsible person.
5. Deal with system of CAPA and maintenance the database.
6. Deal with reprocess/rework/repack and return of product.
7. Monitor in-process control of products’ validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.
8. Document: Prepare, review and train related SOP and batch record.
9. BPCS system: change finished product status and do double check on BOM & API system input.
10. Training the operator, involve qualifying the operator. Have good training skill.
11. Follow up CAPA of complaint and deviation.
12. Perform regular GMP inspection of products as per plan.
13. Coordinator and prepare product annual product review.
14. Monitor in-process control for product, review updated batch record.
15. Deal with the OQA related works of new product issues.
16. Perform other jobs assigned by OQA Section Manager.
17. As quality representative of BPCS system.
18. Deal with TTS/QAA responsibility
19. Prepare report Quality KPI from OQA
20. Review batch record filling.
21. Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures

Specialized 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）

ESSENTIAL
? Education degree and speciality
Bachelor degree or above, major in pharmaceutics.
4 years or above, quality management experiences
Know GSK quality organization and QMS system.
Be familiar with GSK report system /evaluation system/CAP system/audit system.
Know relative state and regional law, such as GMP, MHRA.
Be familiar with all company quality standard, procedure and CP, USP, EP.
? Computer and foreign language level
Fluently use OFFICE software .
Well English reading and speaking skill which is equivalent to CET-4.
? Capability requirement
Good job morality, honest, careful, responsible.
High quality sensitivity.
Good comprehensively analytical ,communication, association, response and innovation ability.
Good learning skill.
General leading and organizing ability.
.
DESIRED
? Good interpersonal skills. 举报 分享

葛兰素史克公司在中国的历史最早可追溯至20世纪初叶。自20世纪80年代以来，在中国政府改革开放政策的感召下，公司在中国积极投资，将最先进的制药技术、最优质的产品、最新型的商业模式、***化的管理理念和市场营销技巧引入了中国。
葛兰素威康和史克必成公司于2000年12月完成全球性合并，2002年，葛兰素史克(中国)投资有限公司全面完成业务整合并正式宣布成立，成为中国目前规模***的跨国制药企业之一。公司业务由处方药、非处方药、疫苗和消费保健品4大部分组成，投资公司和地区总部位于北京，主要业务中心分设在上海、天津和香港。
葛兰素史克是最早在中国成功兴建合资企业的外国制药公司之一。在进入中国的20多年间，葛兰素史克先后成立了5家公司，目前2家为合资企业，总注册资本超过2.3亿美元。目前公司在全国28个主要城市(包括香港)设立了办事机构，在全国拥有近3000名员工，为中国的医药行业培养了一大批高素质的商业管理人员和技术骨干。