南京招聘

职位描述：
Role Purpose岗位目的:

1. Ownership of processes in the manufacturing facilities including process capability, process improvement initiative, process problems ownership and trouble-shooting.
2. Support the product transfer to support GMS network and to achieve the low-cost sourcing strategy from China
3. 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.
4. Responsible for coordinating functional risk management process (if applicable)


Key Responsibilities主要岗位职责:
? 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.

? Leading a team of Process Technical Engineer, Packaging Technologist in TSKF in support the site Technical activities and the product transfer activities.

? Process Ownership
- Taking ownership for the manufacturing process on site to ensure process capability is achieved which includes 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, and carry out trial and process validation.
- Define critical process parameters and implement standardization and control in the manufacturing process by applying tools such as Technical Risk Assessment (TRA), Data Trending, and Root Cause Analysis (RCA)
- Provide technical input for Change control evaluation and initiation, including raw material changes
- Provide support for the Annual Product Review and understand the process capability and implement improvement plan.
- Support the GMS Technology strategy including implementation of PAT to improve the process control or enhance the process understanding
- Provide routine support for the site in term of QMS implementation, updating of relevant SOP, response to regulatory or customer request.
- Provide support for site Quality and EHS tasks achieving.

? Products Transfer
- To lead a product transfer project to ensure it is delivered according to the planned schedule.
- Lead and support the standard product transfer according to GQMP requirement, RPS/NPGS or GSK NPD to TSKF.
- Working closely with Network Change team, donor site and all the commercial markets for the transfer of product into TSKF in accordance to site procedures and standard.
- Taking ownership for the processes associated with product transfers, providing Process Introduction, Qualification and Validation data to meet timelines. Liasing with donating sites/NPD or above site support functions to obtain processing instructions, validation documentation for both product and cleaning validation analysis.
- Carry out process comparison assessment, plant fit and reviewing of processes, material specifications and registration details.
- Manage the product transfer activities to ensure manufacturing and packaging processes are transferred in accordance with cGMP/QMS/CAP/SAP requirements
- Preparation of product transfer documentation including, technology transfer documentation, qualification and validation documentation including protocols, batch records, SOP and so on.

? Products Transfer and Capital projects
- Support the Capital project for facilities and equipment, e.g. design, sourcing of equipment, commissioning and validation (OQ/PQ).
- Preparation of project documentation including URS, qualification and validation documentation including protocols, batch records, SOP and commissioning or qualification documentation

Qualifications / Requirements: (Education / Experience / Competencies)

1. Bachelor or above education in engineering, science or pharmaceutical or related background.
2. At least 5 years experience in pharmaceutical manufacturing environment
3. Good process understanding knowledge and good analytical skills.
4. Good knowledge and understanding of GMP requirement
5. Team player and have a good understanding of other disciplines beyond their own core discipline in order to effectively lead a multi-disciplinary project team.
6. Project management skills and understanding of product transfer requirement
7. Understanding of the regulatory standards which apply to pharmaceutical manufacturing operations, registration requirement.
8. Understanding of manufacturing, packaging processes
9. Controlling of documentation.
10. Good communication and interpersonal skill, Good leadership
11. Good English level including oral communication, writing and listening
12. Good computer skills 举报 分享

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。