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最新职位 Latest Jobs 您目前的位置:首页 > 最新职位
Supplier Quality Auditor
本公司研发为基础的药品和保健品,主要产品包括非处方药、口腔护理品和营养保健饮料。

基础信息

最低学历:本科以上                                             招聘人数:1人
工作经验:3年以上  工作地点:上海、天津、苏州
语言要求:见任职要求                  招聘方式:全职                                            
性别要求:不限 发布日期:2020.03.06

 

岗位要求:

1.Supplier assessment,approval & compliance
•Responsible for performing GMP/Quality System assessments/audits of assigned suppliers within role scope; making a risk based recommendation on the approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.
•Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.
•Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.
•Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.
•Responsible for completion of assigned Supply Chain Risk Assessments for applicable suppliers to support release decisions by THE COMPANY user site “QPs” (Qualified Persons).
•Responsible for supporting change controls from assigned suppliers, as needed, as per the current procedures.
•Responsible for supporting negotiation of Quality Assurance Agreements (QAAs) with assigned suppliers, as needed.

 

2.Risk Management
•Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical,regulatory and quality risks and that appropriate mitigating actions are identified.

 

3.Regulatory/Customer inspection support
•Responsible for providing relevant support to THE COMPANY sites undergoing regulatory/customer inspections,as assigned.

 

4.Internal Supplier Quality processes
•Responsibel for participating, as applicable, in the development of internal Supplier Quality processes to ensure compliance with the THE COMPANY QMS (Quality Management System).
•Responsible for completion of all relevant training curriculums within the stipulated time frame.
•Responsible for following the relevant SQ A&C and QAC procedures.

 

5.Interfaces
•Routinely interfaces with site Quality/Procurement, Procurement Commodity teams, SQ Operations and THE COMPANY suppliers–a two way communication regarding supplier audit results and impact on materials, components and services delivered to the site, supplier audit results, CAPA plans, STPs, etc.

 

职位职责:

The purpose of this job role is to significantly contribute to the The purpose of this job role is to significantly contribute to the assurance that material and service suppliers within the scope of SQ A&C meet applicable Regulatory Authorities and THE COMPANY requirements.

This is delivered by:
•Execution of documented assessments of the GMP and Quality Systems compliance status of assigned suppliers.
•Management of supplier action plans to close identified gaps resulting from said documented assessments.
•Maintenance of audit and user site data for assigned suppliers in THE COMPANY supplier management systems.
•Completion of assigned Supply Chain Risk Assessments for assigned suppliers.
•Providing support of Quality Assurance Agreement negotiations and supplier change control via assigned tasks for assigned suppliers, as applicable.

 

联系方式: 

 联系人  Rose
 联系电话  13372128266
 电子邮件  rose@cs-job.com

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