南京招聘

Responsibility

- Taking ownership for the manufacturing process on site to ensure process capability is achieved which including product quality trending, ownership of processing problems and trouble-shooting.
- Enhance the Process understanding for the manufacturing processing which include process robustness study, initiate process improvement, carry out trial and process validation.
- Define critical process parameters and implement standardization and control in the manufacturing process
- Provide technical input for Change control evaluation and initiation, including raw material changes
- Provide support for site Quality and EHS task achieving.
- Taking ownership for the processes associated with product transfers, providing Process Introduction, Qualification and Validation data to meet timelines
- Carry out process comparison assessment, plant fit and reviewing of processes, material specifications and registration details.
- Support the Capital project for facilities and equipment, e.g. design, sourcing of equipment, commissioning and validation.
- Manage the product transfer activities to ensure manufacturing and packaging processes are transferred in accordance with cGMP/QMS/CAP/SAP requirements
- Preparation of project documentation including URS, technology transfer documentation, qualification and validation documentation including protocols, batch records, SOP and commissioning or qualification documentation
- To comply with QMS and GQMP requirement as assigned, and participate & support the execution of site Quality plan
- Responsible for coordinating functional risk management process
- Ensure department employees attend EHS training on time

.Requirement

1. Bachelor or above education in engineering, science or pharmaceutical or related background.
2. Ideally at least 3 years experience in pharmaceutical manufacturing environment
3. Good process understanding knowledge and good analytical skills.
4. Good knowledge and understanding of GMP requirement
5. Knowledge and understanding of complex manufacturing and packaging processes
6. Standards of hygiene, quality, housekeeping required
7. Controlling of documentation.
8. Good communication and interpersonal skill, Good leadership
9. Good English level including oral communication, writing and listening
10. Good computer skills

中美天津史克制药有限公司是全球***的制药企业之一的葛兰素史克(GSK)与国内大型制药企业天津中新药业股份有限公司和天津太平(集团)有限公司共同投资设立的制药企业。

作为***在华设立的外商合资制药企业之一，中美史克早在1987年便在中国生根。20年来，中美史克一直秉承着大爱铭心的理念，用优质的产品和爱心回报社会。2008年，中美史克家族除了消费者耳熟能详的四大OTC品牌新康泰克、芬必得、百多邦、史克肠虫清外，还成功上市了全球牙医首选推荐的抗牙敏感牙膏舒适达； 新康泰克和芬必得两大品牌家族又添新成员，2008年，新康泰克红色重感装成功上市；2009年，芬必得酚咖片新头痛装的成功上市，中美史克将更好地呵护人们的健康生活。

中美史克注重以人为本，有着激动人心的“3T”企业文化。2007年开始推行的“3T”文化经过一年来的渗透，在2008年更加深入人心。
相互信任(Trust)、开放透明(Transparent)、积极主动 (Take initiative)的“3T企业文化”如今已成为史克员工日常的工作方式，引领着员工与企业共同成长。