Process Engineer -GMS-江苏-苏州
葛兰素史克(中国)处方药事业部
- 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:2013-10-15
- 工作地点:苏州
- 招聘人数:若干
- 职位类别:生物工程/生物制药
职位描述
Job Purpose 岗位目的:
- Knowledge and Technical management for existing product on process understanding, continuous improvement and troubleshooting with technical expertise and tools.
- Assess and Implement Technical Transfer Project aligned with China and Site Strategy.
Key Responsibilities主要岗位职责:
1. Production Support
- To be an expert on specific dosage form or technology;
- Drive technical risk assessment on process understanding and control strategy with knowledge of QbD;
- Drive API/excipient/packaging material source change with mastery of material science;
- Identify and Implement opportunities of continuous improvement with capability of project management
- To be expertise on Lean Manufacturing and Technical GEMBA;
- Lead technical evaluation on equipment sourcing and involve in qualification with Engineering;
- Lead Validation Management
- Lead activities of Product/Process Validation;
- Owner of Batch Record, Process Instruction and Bill of Material from formulation and process aspects.
- Lead Root Cause Analysis for technical issues;
- Performance Management by Data Trending to real time monitoring operations;
- Ensure process is complied with regulatory and policy of GSK from Quality and EHS perspective
- Technical Review and Involvement in Annual Product Review.
- Change and Deviation Management
- Knowledge Management
2. Technical Transfer and Capital projects
- Feasibility Study of new business case with cross-functional team work;
- Implement and lead technical transfer projects with capability of project management;
- Follow and improve technical transfer process stipulated in existing procedure;
- To be coordinator for project implementation;
- To be a technical expert to manage document, process and material with fully technical risk assessment;
- To be expertise on Lean Manufacturing and Technical GEMBA;
- Lead activities of Product/Process Validation;
- Change and Deviation Management
- Ensure process is complied with regulatory and policy of GSK from Quality and EHS perspective
- Knowledge Management 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 Masters Degree in Chemical Engineering, Science or Pharmaceutical related subjects. 2. Preferred experience in a pharmaceutical manufacturing environment. 3. Understanding of the Chinese Regulatory Environment and the Regulations. 4. Understanding of Quality and EHS requirements associated with site operation and technical transfer 5. High capability in Project management. 6. Good process understanding knowledge and good analytical skills. 7. Good understanding of the value stream processes and vision factory. 8. Good communication and interpersonal skill, to include oral communication, writing and listening in English 9. Self starter with a sense of urgency, with ability to influence at all levels 10. 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. Desirable: · Technical Risk Assessment · Root Cause Analysis · Project Management · Lean · Technical Transfer
公司介绍
作为世界领先的制药业巨擘,葛兰素史克公司秉承以研究开发为基础的一贯理念,凭藉公司本身的技术潜力和资源优势,在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司,由葛兰素威康和史克必成强强联合,于2000年12月成立。两家公司的历史均可追溯至19世纪中叶,各自在一个多世纪的不断创新和数次合并中,在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并,为葛兰素史克成为行业中无可争议的领导者奠定了基础,并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国,以美国为业务营运中心,在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平,在疫苗领域雄居行业榜首。此外,公司在消费保健领域也居世界领先地位,主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前,公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化,葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究,目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础(science-driven),通过生物学,化学以及最新技术,创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动,并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
更多信息请访问我们的网站:www.gsk.com or www.gskchina.com
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:上海市西藏中路168号都市总部大楼6楼
- 邮政编码:200001