长沙招聘

职位描述：
Job Purpose 岗位目的:
? Lead/Support the new product transfer to support GMS strategy.
? Ownership of processes in the manufacturing facilities including process capability, process improvement initiative, process problems ownership and trouble-shooting.
? 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.
? Responsible for coordinating functional risk management process (if applicable)

Key Responsibilities主要岗位职责:
1. 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.

2. Process Ownership
? 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 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 task achieving.

3. Products Transfer and Capital projects
? Taking ownership for the processes associated with product transfers, providing Process Introduction, Qualification and Validation data to meet timelines. Liasing with donating sites or TSK&F R&D 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.
? Support the standard product transfer according to blue-print, within GMS China, from RPS/NPGS sites or from TSK&F R&D.
? Support the Capital project for facilities and equipment, e.g. design, sourcing of equipment, commissioning and validation (OQ/PQ).
? 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

4. Risk Management and Internal Control Process (For Risk Champions)
? Responsible for coordinating functional risk management process

5. EHS Process(For EHS Coordinator)
? Understand the applicable EHS requirements and Company policy, follow EHS standard operating procedures.
? According to EHS audit SOP, EHS coordinator need to finish Dept. L1 audit on time and make sure the corrective actions are done timely.
? Support EHS L2/L3/L4 audit and ensure all the corrective actions are done on time.
? Ensure department employees attend EHS training on time.

Accountability 责任:

1.Process Ownership
? Accountable for commercial products’ process capability and process performance to deliver good quality product in a timely and effective manner

2. Products Transfer and Capital projects
? Accountable for the timely delivery of the product transfer in accordance to the project timeline and delivering activities as in the plan.
? Accountable for success of product transfer including defining the processes to be validated, identification of critical process parameters and knowledge management of information transferred.

Complexity 复杂程度(optional):
1. Tablet manufacturing processes or capsule manufacturing processes knowledge
2. Meeting the changing business needs and handling unforeseen circumstances in the process or process equipment.
3. Working with cross functional teams within site, across sites and above site project team members which may involve many countries within the GSK network e.g. Aranda, Crawley, Boronia and so on
4. Plan, cordinate and execution of process trial and process validation activities
5. Support the low cost sourcing raw materials by providing technical evaluation.

Specialized Knowledge 专业知识:
? Bachelor or above education in engineering, science or pharmaceutical or related background.
? Ideally at least 3 years experience in pharmaceutical manufacturing environment
? Good process understanding knowledge and good analytical skills.
? Good knowledge and understanding of GMP requirement
? Knowledge and understanding of complex manufacturing and packaging processes
? Standards of hygiene, quality, housekeeping required
? Controlling of documentation.
? Good communication and interpersonal skill, Good leadership
? Good English level including oral communication, writing and listening
? 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。