黄山招聘

Job Description
工作目标  Objective
Responsible for the activities necessary to ensure that R&D functions are operating in full compliance with sound scientific practice, current good manufacturing practices and with Johnson and Johnson policies and procedures. These activities will include but not limited to: Participating the internal audit and lab walk through; Documentation review and approval; Review of SOPs; Design Control, Providing quality oversight and support.

工作主要职责 Responsibility  
1, Participates in the execution of systems aimed at evaluating (e.g. the internal audit and lab walk through) and maintaining quality and compliance
2, Communicates effectively with professional staff and leadership across departments on document review findings
3, Work as Training Process Owner (AP R&D): A subject matter expert responsible for utilizing an LMS or manual system for creating, maintaining and tracking training
·         Provides oversight for curricula creation and revisions.
·         Responsible for Training Committee Meetings and provides system/best practice updates.
·         Consultant to the Process Owners on the development of training materials.
·         System Training Administrator for AP R&D.
·         Responsible for supplying Training Metrics.
4, Supporting deployment of design control (for Medical Device that required design control) and product risk management in Asia Pacific, closely coordinating design control activities with R&D, Regulatory Affairs, Safety and Q&C
5, Coordinate metrics reporting for all AP R&D sites (including but not limited to R&D Shanghai, R&D Singapore, R&D India, and other R&D regional Groups/Functions) and support the quality data review preparation.
6, Work as R&D Shanghai record control coordinator/process owner:
·         Tracking the procedure periodic review status
·         Maintain the accuracy of quality addendum
·         Notebook and logbook issuance
·         R&D Shanghai Archive Room Coordinator
7, Collaborate with regional supplier management coordinator, to support the supplier profile maintenance and supplier qualification
8, Reviews local procedures from GMP perspective and suggests process improvements and contributes to the ongoing development of new procedures
9, Performs other duties as assigned

工作评估标准 KPIs 
On time delivery
Error free performance
Customer satisfaction

工作要求  Requirements

财务职责 Financial responsibility:
(预算, 成本, 销售等, in terms of budget, cost, sales etc) )

背景Background  (学历、经验和能力要求)

学历要求education level requirement:
Bachelor degree

工作经验 working experience:                             
At least 3 years professional experience working in the QA, and Pharmaceutical Industry QA related working experience is preferred.
Sufficient in English reading and writing

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