Senior QA Specialist -
利洁时(中国)投资有限公司
- 公司规模：5000-10000人
- 公司行业：快速消费品(食品、饮料、化妆品) 制药/生物工程
职位信息
- 发布日期：2017-11-28
- 工作地点：上海
- 工作经验：无工作经验
- 语言要求：英语
- 职位月薪：15-28万/年
- 职位类别：质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述：
Job Summary
Develop and implement an effective Quality Management System across Product Life Cycle, focused on China Cross Border Business Operation (overseas products commercialized by RB, or RB Company in China market) and support the China Business Unit core processes - Best practices reflected into clear local SOP
The individual should have knowledge of the Principles and Guidelines of GMP and also the GSP/GDP, to make sure that the county unit (China) processes are complaint with RB and local standards.
Job Scopes
? Develop and implement all core process controls of Cross Border operational model for risk management and quality system improvement: Change Control, Complaints Management, GDP Compliance (Storage and Dist. Conditions), and Overall Performance monitor.
? Good Distribution Practices Minimum standards in place – all China and Cross Border warehouses (under RB domain) with full compliance vs RB GDP and local requirements
? Manage Change Control process (in-market risk impact analysis) for Cross Border New Products (NPD) and Changes related to this Business Operational Model – Quality Rep for Risk Impact Analysis
? Monitor Post Market Surveillance (tracking of performance in market), providing clear KPIs
? Lead effective process for Complaints Management – root cause, investigation and CAPA agreement with issues-sourcing (monitor till closure). Supported by clear process KPIs (timely, response level, CAPA status). Ensure data integrity (records).
Responsibility
? Develop and implement all core process controls of Cross Border operational model for risk management and quality system improvement: Change Control, Complaints Management, GDP Compliance (Storage and Dist. Conditions), and Overall Performance monitor.
? Ensure Good Distribution Practices Minimum standards are in place – all China and Cross Border warehouses (under RB domain) with full compliance vs RB GDP and local requirements
? Keep Technical Agreements with all involved third-parties up to date, including clear roles and responsibilities and minimum requirements
? Manage Change Control process (in-market risk impact analysis) for Cross Border New Products (NPD) and Changes related to this Business Operational Model – Quality Rep for Risk Impact Analysis
? Monitor Post Market Surveillance (tracking of performance in market), providing clear KPIs
? Manage Intercompany issues resolution (management of complaints, Q&A)
? Lead effective process for Complaints Management:
o Root cause, investigation and CAPA agreement with issues-sourcing (monitor till closure). Supported by clear process KPIs (timely, response level, CAPA status). Ensure data integrity (records).
o Monitor complaint trend and analysis complaint data, drive CAPA as needed with relevant stakeholders
o Communicate complaint investigation result to internal customer to close at customer perspective.
? Support Embellishment activities compliance and Continuous Improvement – SOPs, Tech Agreements, Work Instructions, Tech Visits and Internal audits
? Support GDP/GSP internal audit plan execution and CAPA tracking till completion.
Qualification
? At least 4 years of QA experience working in a quality in a Healthcare, Hygiene, Pharmaceutical, or Medical Device related industry.
? Knowledge of typical regulatory requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 111/ 210/ 211/ 820
? Quality experience on Manufacturing is preferred, such as in process QA/QC.
? Results oriented, entrepreneurial and self-motivating
? Communication Agility both written and oral (Chinese native and English)
? Open mind and eager to learn
? Presentation skills
Job Summary
Develop and implement an effective Quality Management System across Product Life Cycle, focused on China Cross Border Business Operation (overseas products commercialized by RB, or RB Company in China market) and support the China Business Unit core processes - Best practices reflected into clear local SOP
The individual should have knowledge of the Principles and Guidelines of GMP and also the GSP/GDP, to make sure that the county unit (China) processes are complaint with RB and local standards.
Job Scopes
? Develop and implement all core process controls of Cross Border operational model for risk management and quality system improvement: Change Control, Complaints Management, GDP Compliance (Storage and Dist. Conditions), and Overall Performance monitor.
? Good Distribution Practices Minimum standards in place – all China and Cross Border warehouses (under RB domain) with full compliance vs RB GDP and local requirements
? Manage Change Control process (in-market risk impact analysis) for Cross Border New Products (NPD) and Changes related to this Business Operational Model – Quality Rep for Risk Impact Analysis
? Monitor Post Market Surveillance (tracking of performance in market), providing clear KPIs
? Lead effective process for Complaints Management – root cause, investigation and CAPA agreement with issues-sourcing (monitor till closure). Supported by clear process KPIs (timely, response level, CAPA status). Ensure data integrity (records).
Responsibility
? Develop and implement all core process controls of Cross Border operational model for risk management and quality system improvement: Change Control, Complaints Management, GDP Compliance (Storage and Dist. Conditions), and Overall Performance monitor.
? Ensure Good Distribution Practices Minimum standards are in place – all China and Cross Border warehouses (under RB domain) with full compliance vs RB GDP and local requirements
? Keep Technical Agreements with all involved third-parties up to date, including clear roles and responsibilities and minimum requirements
? Manage Change Control process (in-market risk impact analysis) for Cross Border New Products (NPD) and Changes related to this Business Operational Model – Quality Rep for Risk Impact Analysis
? Monitor Post Market Surveillance (tracking of performance in market), providing clear KPIs
? Manage Intercompany issues resolution (management of complaints, Q&A)
? Lead effective process for Complaints Management:
o Root cause, investigation and CAPA agreement with issues-sourcing (monitor till closure). Supported by clear process KPIs (timely, response level, CAPA status). Ensure data integrity (records).
o Monitor complaint trend and analysis complaint data, drive CAPA as needed with relevant stakeholders
o Communicate complaint investigation result to internal customer to close at customer perspective.
? Support Embellishment activities compliance and Continuous Improvement – SOPs, Tech Agreements, Work Instructions, Tech Visits and Internal audits
? Support GDP/GSP internal audit plan execution and CAPA tracking till completion.
Qualification
? At least 4 years of QA experience working in a quality in a Healthcare, Hygiene, Pharmaceutical, or Medical Device related industry.
? Knowledge of typical regulatory requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 111/ 210/ 211/ 820
? Quality experience on Manufacturing is preferred, such as in process QA/QC.
? Results oriented, entrepreneurial and self-motivating
? Communication Agility both written and oral (Chinese native and English)
? Open mind and eager to learn
? Presentation skills
职能类别： 质量管理/测试工程师(QA/QC工程师)
公司介绍
利洁时是全球500强企业，是全球最大的家用清洁及个人护理消费品公司之一，总部位于英国伦敦。在60个国家运作高品质的家用清洁用品、个人护理用品和药品，产品行销180个国家和地区。我们的历史可以追溯到18世纪：在英国生产面粉的Reckitt和在德国生产工业化学原料的Benckiser。1888年开始，我们已经开始在伦敦股票交易所上市，通过合资，以及有选择性的并购，我们已经成为富时指数前25位的全球性公司。
利洁时在中国的发展一直以生产和推广高品质的家庭清洁和个人卫生护理用品、推动中国健康护理事业的发展目标。作为蜚声国际的跨国企业，利洁时在中国市场生产和销售高质量的知名品牌家庭清洁产品。
开发极具潜力的市场，始终是利洁时公司投资的核心战略之一。1995年利洁时来到中国，在广州成立了第一家合资企业-利高曼（广州）有限公司，1996年与湖北活力28集团合资组建了湖北活力美洁时洗涤用品有限公司，从此扎根荆州，开始了利洁时投资中国市场的历程。随着中国国际地位的提升，在加大投资及完成中国区域资源整合的同时，利洁时更坚定了在中国投资的信心。2006年，在中国成立了利洁时家化（中国）有限公司（利洁时全球全资子公司）。为了使中国区的工厂真正成为国际生产基地，几年来利洁时在中国的投资势头不减，在组织结构调整和人员配备方面更是格外重视。2010年随着利洁时全球收购了SSL集团，利洁时在中国增加了新的产品品牌，工厂以及团队。
目前利洁时中国的品牌有：
Dettol （滴露）
Veet （薇婷）
Finish （亮碟）
Airwick (安悦嘉）
Dosia （巧手）
Durex （杜蕾斯）
Scholl （爽健）
Vanish（渍无踪）
我们以我们自己在这个高度竞争的全球市场中创造的成绩而骄傲，并深刻意识到我们的成功是直接和我们善于接受挑战，充满热情和才华的员工联系在一起的。
想要了解我们更多的历史和信息，请参阅公司网站 www.rb.com
利洁时在中国的发展一直以生产和推广高品质的家庭清洁和个人卫生护理用品、推动中国健康护理事业的发展目标。作为蜚声国际的跨国企业，利洁时在中国市场生产和销售高质量的知名品牌家庭清洁产品。
开发极具潜力的市场，始终是利洁时公司投资的核心战略之一。1995年利洁时来到中国，在广州成立了第一家合资企业-利高曼（广州）有限公司，1996年与湖北活力28集团合资组建了湖北活力美洁时洗涤用品有限公司，从此扎根荆州，开始了利洁时投资中国市场的历程。随着中国国际地位的提升，在加大投资及完成中国区域资源整合的同时，利洁时更坚定了在中国投资的信心。2006年，在中国成立了利洁时家化（中国）有限公司（利洁时全球全资子公司）。为了使中国区的工厂真正成为国际生产基地，几年来利洁时在中国的投资势头不减，在组织结构调整和人员配备方面更是格外重视。2010年随着利洁时全球收购了SSL集团，利洁时在中国增加了新的产品品牌，工厂以及团队。
目前利洁时中国的品牌有：
Dettol （滴露）
Veet （薇婷）
Finish （亮碟）
Airwick (安悦嘉）
Dosia （巧手）
Durex （杜蕾斯）
Scholl （爽健）
Vanish（渍无踪）
我们以我们自己在这个高度竞争的全球市场中创造的成绩而骄傲，并深刻意识到我们的成功是直接和我们善于接受挑战，充满热情和才华的员工联系在一起的。
想要了解我们更多的历史和信息，请参阅公司网站 www.rb.com
联系方式
- 公司地址：徐汇区港汇广场42层 (邮编：200000)