Global Quality & Regulatory Affairs Manager
安迪苏生命科学制品(上海)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:贸易/进出口 制药/生物工程
职位信息
- 发布日期:2016-10-17
- 工作地点:上海
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:硕士
- 语言要求:英语 精通
- 职位月薪:15000-19999/月
- 职位类别:化工技术应用/化工工程师 药品生产/质量管理
职位描述
职位描述:
Title: Global Quality & Regulatory Affairs Manager – Vitamins
Reports and location
- Reports hierarchically to the Global Vitamins BU Manager & Commercial Director based in China
- Reports functionally to the Adisseo Market Access Head (based in France Antony)
- Located in the office of Adisseo Life Science at Shanghai
Functional contacts
- BU Microvit Team (Supply chain, Purchasing, Commercial) and sales regions
- Chinese and oversea suppliers
- Adisseo quality & Market Access team (located in China and France)
MAIN RESPONSABILITIES
- Responsible for the quality of global vitamin business.
- Implement program to continuously improve vitamin product quality
- Responsible for BU complaints from global customers.
- Guarantee quality control of vitamin products and build relationship with third party Lab.
- Responsible for vitamin product regulatory affairs.
- Customer technical relationship
DETAILLED RESPONSABILITIES
? Responsible for the quality of global vitamin business.
- Select, audit and approve new suppliers according to ISO 9001, FAMI-QS, HACCP, GMP and enterprise global standard.
- Optimize new supplier selection process, develop supplier audit and evaluation matrix.
- Ensure the compliance of quality requirements by auditing suppliers (mainly Chinese suppliers), set up and continuously improve quality assurance system for Vitamin sourcing.
? Responsible for BU complaints from global customers.
- Responsible for complaints from global customers, set up a quick action plan to avoid new issue, and follow up suppliers and plant's corrective actions.
- Handle complaints using SAP QM module, BI to follow enterprise KPI and monitor complaint status.
- In case of cost impact for Adisseo, the incumbent will help the buyer to negotiate reimbursement with the suppliers.
? Guarantee quality control of vitamin products and build relationship with third party Lab.
- Set up a quality control system based on random sampling of the products and analyze by a local network of labs to reduce quality risk.
- Manage local QC lab and timely conduct routine test and sample qualification using GC, HPLC, viscosity, PH meter, etc.
- Develop and train new vitamin test method into local QC Lab and make sure the data of Local QC Lab reliable.
- Maintain relationship with relevant third-party labs and national analytical labs in China to conduct quality control.
? Responsible for vitamin product regulatory affairs.
- Communicate with Global Regulatory Affairs team to monitor and collect EU Regulation & Directive to review vitamin product compliance.
- Follow up the changes of relevant regulations and provide report timely to meet product compliance.
- Communicate and train supplier to modify document or product to comply with EU standard.
? Customer Technical Relationship
- To be the direct link between the customers and BU concerning the quality of products
- To handle and advise the technical enquiries of the global vitamins clients
- To prepare and formalize vitamins technical and quality training for global vitamins customers.
Profile & Business requirements
? Fluent English in written and spoken.
? Master degree (chemistry, pharmacy, quality control or production management).
? Feed, Food or Pharmaceutical industry experiences (5 years above) in quality management or supplier management, a regulatory affair experience will be appreciated.
? Experience to work in multinational company with high level of autonomy management and matrix organization.
? Strong skills and experiences in supply sourcing, supplier management and or quality system audit.
? Knowledge of standard quality tools (e.g. HACCP, 6 sigma, SPC, Kaisen, FAMI-QS, HACCP, ISO certificate).
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Title: Global Quality & Regulatory Affairs Manager – Vitamins
Reports and location
- Reports hierarchically to the Global Vitamins BU Manager & Commercial Director based in China
- Reports functionally to the Adisseo Market Access Head (based in France Antony)
- Located in the office of Adisseo Life Science at Shanghai
Functional contacts
- BU Microvit Team (Supply chain, Purchasing, Commercial) and sales regions
- Chinese and oversea suppliers
- Adisseo quality & Market Access team (located in China and France)
MAIN RESPONSABILITIES
- Responsible for the quality of global vitamin business.
- Implement program to continuously improve vitamin product quality
- Responsible for BU complaints from global customers.
- Guarantee quality control of vitamin products and build relationship with third party Lab.
- Responsible for vitamin product regulatory affairs.
- Customer technical relationship
DETAILLED RESPONSABILITIES
? Responsible for the quality of global vitamin business.
- Select, audit and approve new suppliers according to ISO 9001, FAMI-QS, HACCP, GMP and enterprise global standard.
- Optimize new supplier selection process, develop supplier audit and evaluation matrix.
- Ensure the compliance of quality requirements by auditing suppliers (mainly Chinese suppliers), set up and continuously improve quality assurance system for Vitamin sourcing.
? Responsible for BU complaints from global customers.
- Responsible for complaints from global customers, set up a quick action plan to avoid new issue, and follow up suppliers and plant's corrective actions.
- Handle complaints using SAP QM module, BI to follow enterprise KPI and monitor complaint status.
- In case of cost impact for Adisseo, the incumbent will help the buyer to negotiate reimbursement with the suppliers.
? Guarantee quality control of vitamin products and build relationship with third party Lab.
- Set up a quality control system based on random sampling of the products and analyze by a local network of labs to reduce quality risk.
- Manage local QC lab and timely conduct routine test and sample qualification using GC, HPLC, viscosity, PH meter, etc.
- Develop and train new vitamin test method into local QC Lab and make sure the data of Local QC Lab reliable.
- Maintain relationship with relevant third-party labs and national analytical labs in China to conduct quality control.
? Responsible for vitamin product regulatory affairs.
- Communicate with Global Regulatory Affairs team to monitor and collect EU Regulation & Directive to review vitamin product compliance.
- Follow up the changes of relevant regulations and provide report timely to meet product compliance.
- Communicate and train supplier to modify document or product to comply with EU standard.
? Customer Technical Relationship
- To be the direct link between the customers and BU concerning the quality of products
- To handle and advise the technical enquiries of the global vitamins clients
- To prepare and formalize vitamins technical and quality training for global vitamins customers.
Profile & Business requirements
? Fluent English in written and spoken.
? Master degree (chemistry, pharmacy, quality control or production management).
? Feed, Food or Pharmaceutical industry experiences (5 years above) in quality management or supplier management, a regulatory affair experience will be appreciated.
? Experience to work in multinational company with high level of autonomy management and matrix organization.
? Strong skills and experiences in supply sourcing, supplier management and or quality system audit.
? Knowledge of standard quality tools (e.g. HACCP, 6 sigma, SPC, Kaisen, FAMI-QS, HACCP, ISO certificate).
职能类别: 化工技术应用/化工工程师 药品生产/质量管理
关键字: quality control regulatory manager chemistry
公司介绍
安迪苏公司是一家总部位于巴黎的跨国公司,其业务范围覆盖全球120多个国家或地区,属于全球营养性饲料添加剂领域的领先者,以专业生产罗迪美、固体和液体蛋氨酸、麦可维、维生素、罗酶宝酶制剂系列产品为主。
联系方式
- 公司地址:上班地址:浦东新区芳甸路1155号1003-1008室