Global Irelease GMP QA Manager(Third Party)
Pharma-北京诺华制药有限公司
- 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:2013-10-14
- 工作地点:上海
- 招聘人数:若干
- 职位类别:药品生产/质量管理
职位描述
Job Purpose
? Act as Roll-out supporter for iRelease for functions at headquarters and in-country organi-zations
? Act as SME for iRelease functionalities
? Analyse key performance indicators of processes in iRelease
Major Activities
? Act as Roll-out supporter for iRelease
? Assist informal and PQ testing of new software releases of iRelease
? Assist preparing training material for iRelease and process documentation
? Organize and conduct training sessions for iRelease
? Assist in-country organization to set-up local depots and iRelease processes
? Act as SME for iRelease functionalities
? Assist in building helpdesk L1 support with selected vendors
? Provide helpdesk L2 support for iRelease users
? Assist building knowledge base for helpdesk
? Build and maintain issue log for iRelease and mitigations
? Analyse key performance indicators of processes in iRelease
Key Performance Indicators
? Accountability for costs, quality, quantity, and timelines for all assigned tasks.
? Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environ-ment (HSE), and information security (ISEC) standards.
? Feedback from user community, other team leaders, operations work stream and global Head iRelease
? Refer to annual individual and team objective setting.
Ideal Background (State the preferred education and experience level)
Education(minimum/desirable):
? Minimum: Degree in scientific or relevant discipline (BS or equivalent)
? Desirable : Degree in scientific or relevant discipline
Languages:
? Fluent English (oral and written) required
? Fluent in site-language desirable
Experience/Professional
requirement:
? Ability address issues pro-active during implementation.
? Ability to work in situations of ambiguity
? Good communication, negotiation and interpersonal skills.
Desirable:
? Basic knowledge of relevant GxPs and Novartis policies as well as applicable national and multinational regulations.
? Basic knowledge of processes and interfaces in the development of new drugs would be helpful
? Good cross-functional perspective to establish key rela-tionships and ensure effective alignment with CPOs and headquarters
? At least 1 year of relevant experience in Pharmaceutical Development, Clinical Development, Clinical Supply Operations, Project Management or related Field
? Act as Roll-out supporter for iRelease for functions at headquarters and in-country organi-zations
? Act as SME for iRelease functionalities
? Analyse key performance indicators of processes in iRelease
Major Activities
? Act as Roll-out supporter for iRelease
? Assist informal and PQ testing of new software releases of iRelease
? Assist preparing training material for iRelease and process documentation
? Organize and conduct training sessions for iRelease
? Assist in-country organization to set-up local depots and iRelease processes
? Act as SME for iRelease functionalities
? Assist in building helpdesk L1 support with selected vendors
? Provide helpdesk L2 support for iRelease users
? Assist building knowledge base for helpdesk
? Build and maintain issue log for iRelease and mitigations
? Analyse key performance indicators of processes in iRelease
Key Performance Indicators
? Accountability for costs, quality, quantity, and timelines for all assigned tasks.
? Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environ-ment (HSE), and information security (ISEC) standards.
? Feedback from user community, other team leaders, operations work stream and global Head iRelease
? Refer to annual individual and team objective setting.
Ideal Background (State the preferred education and experience level)
Education(minimum/desirable):
? Minimum: Degree in scientific or relevant discipline (BS or equivalent)
? Desirable : Degree in scientific or relevant discipline
Languages:
? Fluent English (oral and written) required
? Fluent in site-language desirable
Experience/Professional
requirement:
? Ability address issues pro-active during implementation.
? Ability to work in situations of ambiguity
? Good communication, negotiation and interpersonal skills.
Desirable:
? Basic knowledge of relevant GxPs and Novartis policies as well as applicable national and multinational regulations.
? Basic knowledge of processes and interfaces in the development of new drugs would be helpful
? Good cross-functional perspective to establish key rela-tionships and ensure effective alignment with CPOs and headquarters
? At least 1 year of relevant experience in Pharmaceutical Development, Clinical Development, Clinical Supply Operations, Project Management or related Field
公司介绍
北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药,涵盖的疾病领域包括:心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。
“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年,总部设在北京,隶属于瑞士诺华公司。
诺华公司致力于为患者及社会提供创新医药保健解决方案,以满足其日益变化的健康需求。2011年,集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元(去除减值及摊销后为92亿美元)。诺华集团总部位于瑞士巴塞尔,业务遍及全球140多个国家和地区,拥有124,000位全职员工。诺华集团立足在中国的长期发展,重要战略投资包括位于上海的综合性生物医学研发中心,以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息,敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。
“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年,总部设在北京,隶属于瑞士诺华公司。
诺华公司致力于为患者及社会提供创新医药保健解决方案,以满足其日益变化的健康需求。2011年,集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元(去除减值及摊销后为92亿美元)。诺华集团总部位于瑞士巴塞尔,业务遍及全球140多个国家和地区,拥有124,000位全职员工。诺华集团立足在中国的长期发展,重要战略投资包括位于上海的综合性生物医学研发中心,以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息,敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。
联系方式
- Email:staffing.center@novartis.com
- 公司地址:上班地址:建国门外大街1号国贸大厦2座