JOB DESCRIPTION:

主要职责
Core Job Responsibilities

-    作为法规合规专家参与公司的各种项目工作，协调QA、RA部门对各个项目的支持工作。
-    Participate in projects of plant or affiliate as regulatory compliance representative, coordinate QA or RA issues within quality department and reach out to regulatory department.

-    准备外部申报/注册资料如生产许可证、CIQ证书、FSMP及IFM注册申报等，与外部机构办事人员联系申报事项。
-    Prepare dossier for external application/registration such as ML, CIQ, FSMP, etc. Communicate with external agency contactor for application issues.
-    
-    负责工厂法规方面SOP及文件的维护，及对工厂的法规培训工作
-    Responsible for plant regulatory SOP and documents maintenance, responsible for plant regulatory compliance training activities.

-    跟踪中国法规发展趋势，组织跨部门团队进行差距分析，并制定行动计划。
-    Track newly issued or revised chines regulations, have gap assessment and coordinate actions with cross function team.

-    参与支持质量体系的其他工作，如内审等。
-    Maintenance site integrity management system, participate and support quality system related work, for example, internal audit. 

-    负责管理政府现场取样工作。
-    Responsible for managing government on-site sampling work.

职位职责/范围Position Accountability / Scope
Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position.

-    向法规合规主管汇报，协助婴幼儿配方乳粉、特殊医学用途配方食品及其他相关产品的法规事务。
-    Report to regulatory compliance supervisor, responsible for regulatory issue of IFM products, FSMP and other products in JX plant

-    组织内部相关部门，准备向外部机构的申请或注册工作资料，并协助完成各项内审、外审活动。
-    Ensure compliance of plant operation and successful application/registration in external agency including FDA, MOH, CIQ, etc.

最低学历要求Minimum Education
-    食品科学、食品工程、食品分析等相关专业，本科及以上学历。
-    Bachelor Degree and above in food science, food technology, food analysis or related subjects 
最低经验/培训要求Minimum Experience / Training Required
-    对GMP、食品安全法规、婴幼儿配方乳粉、特医食品及乳制品国标有较好了解。
-    Good practical knowledge of GMP, food safety regulation, GB compliance in infant formula food, FSMP and dairy food manufacturing

-    对HACCP、诚信体系、ISO9001等体系管理知识有较好了解。
-    Have good knowledge in HACCP, Integrity Management System, ISO 9001 etc, system.
-    对食品生产过程及工艺有较好了解。
-    Have good understanding of food manufacturing process.

-    具备流利的英语口语及充足的书面沟通能力。
-    Fluent spoken English and sufficient written communication skills.
 

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

China > Jiaxing : 681 Shengtang Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable