重庆 [切换城市] 重庆招聘重庆生物/制药/医疗器械招聘重庆药品生产/质量管理招聘

NPI Technologist

中美天津史克制药有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2014-03-04
  • 工作地点:天津
  • 招聘人数:1
  • 工作经验:三年以上
  • 学历要求:本科
  • 职位类别:药品生产/质量管理  

职位描述

Key Responsibilities主要岗位职责:

Overall responsibility:

  1. Responsible for assessment and execution of technical transfer and NPI manufacturing/packing process on site and assessing risk and its mitigation
  2. Implement and maintain the Process understanding, capability and control for the implementation of NPI, ensuring the right level of detail is followed to ensure Zero defect at an early stage of manufacturing and packaging processing, this may include process robustness, maintenance, process improvement, supporting execution of trials and process validation.
  3. Play planning role of each project and track closely.
  4. Risk concept through project management process, support NPI Section manager identify and manage any potential risks from business, quality and EHS point of views.
  5. Ensure risks are highlighted and managed through appropriate authoring of risk documents and ensure closed with evidence and filed appropriately

Project management:

  1. Coordinate and finalize SIA for each product.
  2. Raise change control and track all change actions, in line with GQMP and SOP requirement, ensuring change are completed appropriately.
  3. Set up the detailed Microsoft project plan after team walk through, project team meeting etc.
  4. Prepare day to day plan depend on different project progress, run daily project meeting at that stage. Working with planning, Logistics team to make sure build NPI in routine production plan.
  5. Communicate and coordinate daily trial, PV etc activities, make sure no any mis-communication during transfer process.

Specialised 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)

  1. Bachelor or above education in science, Project Management or pharmaceutical or related background.
  2. 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 and local regulatory requirements
  5. Knowledge and understanding of complex manufacturing and packaging processes
  6. Good communication and interpersonal skill
  7. Good English level including oral communication, writing and listening
  8. Implement sustainable systems for product and process performance trending and analysis for products with the appropriate use of statistics
  9. Will be capable of applying standard work routines to new and existing product processes
  10. The role is based at GSK-T, and operates cross-functionally across the individual will also be expected to interact with, and influence individuals at different levels and different functions within the GSK organization such as CoE and R&D
  11. The role also requires sufficient personal resource management skills to support individual projects and group deliverables.

公司介绍

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。

联系方式

  • Email:jenny.y.zhang@gsk.com
  • 公司地址:天津市