研发质量经理
强生(中国)投资有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2021-06-03
- 工作地点:上海-闵行区
- 招聘人数:若干人
- 工作经验:8-9年经验
- 学历要求:本科
- 职位月薪:3-4万/月
- 职位类别:药品生产/质量管理
职位描述
Position Description
Overall Quality oversight and responsibility for Shanghai Technology and Research Center (China), Singapore Research Center and Thailand Packaging Laboratory, ensuring quality and compliance to internal and external requirements during product development. Additionally, this role will be the key R&D Q&C contact of Selfcare R&D on various Selfcare initiatives.
Position Summary
· Lead implementation of quality systems and controls that are appropriate, effective and efficient during product development to ensure that R&D is operating with sound scientific practice and in compliance with current Good Manufacturing Practices (cGMP), regulations and Quality Policy Standards
· Understand regulations to provide risk analysis guidance and make decisions about R&D GxP activities as they apply to products, processes, practices and procedures.
· Functions as an advisor concerning Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP), and provides appropriate compliance guidance to staff and R&D personnel.
· Contributes to implementation of processes and systems that lead to collection of data relevant to reporting and evaluation of quality metrics. Additionally, using available data and relevant metrics, collaborates with other members of STaR, SRC and Thailand Laboratory teams in identifying areas of continuous improvement
· Partners with Selfcare R&D in ensuring compliance and robustness of new product and life cycle management
· Ensure audit readiness of STaR and Singapore Research Center
· Ensures that R&D suppliers are qualified and managed according to internal requirements
Responsible for the development of R&D Q&C staff based in STaR including management development and training to meet current and future business needs.
EDUCATION, EXPERIENCE, KNOWLEDGE and ABILITY REQUIREMENTS
· At minimum, Bachelor’s degree on Pharm, Chemistry or Science/Engineering. Master’s degree is desirable
· Extensive experience in a regulated industry
· Expert knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices)
· Experience of the overall product development process
· Ability to provide guidance, collaborate, negotiate, and effectively coach and direct departmental staff and others to ensure an ongoing state of compliance. Strong people management experience.
· Ability to engage and align with diverse and dispersed organizations and functions.
· Ability to negotiate, influence and lead with and without direct line authority, and to engage others and lead an organization through continuous improvement and change.
· Ability to work and make compliant decisions independently and on multiple projects.
· Strong English communication and proficiencies in Microsoft Office applications.
职能类别:药品生产/质量管理
公司介绍
强生于1985年在华创立了***家合资企业。 多年来,强生不断发挥行业领军作用,以创新、高质量的产品和服务,为中国亿万家庭带来健康。如今,强生在中国的业务涉及消费品、制药、医疗器材三大领域,在北京、上海、广州、苏州、西安等90多个城市,拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地,以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业;并通过实现从早期研发到临床应用,致力于加速中国创新产品的研发,促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心,将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构,以及优秀人才的合作,通过提供资金、专业知识和技术,共同将雏形创新转化为医学临床应用的成果,强生并在中国建立全球肺癌研究中心,以满足中国及国际市场的需求,造福病患。
强生心系中国的发展和进步,致力于成为优秀的企业公民。强生积极参与各类重大活动,助力中国的社会经济发展, 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺,强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力,更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐,为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉,充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年,强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜,位列总榜第13名,居全球制药行业榜首。
联系方式
- Email:cke1@its.jnj.com
- 公司地址:深圳