招聘人数:若干
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
语言要求:
英语
Main Job responsibilities:
Support the QMS team to develop, implement, maintain and improve the quality system of the sites in accordance with Worldwide Quality strategy and regulation requirements
Develop and provide related trainings to employees based on applicable regulatory requirements.
Serves as EtQ administrator (NC, CAPA and Audit) for the site and responsible for all tasks associated in accordance with all applicable Worldwide Quality requirements
Follow up with individuals for the implementation of actions related to NC/CAPA/Audit as required
Responsible for post-delivery quality control as the site SME, such as complaint handling, China Adverse Event Reporting and Field Action, etc.
?Serves as the local complaint handling coordinator that ensure complaint investigation are completed in time and escalate risk identified
?Work with Business Quality, Regulatory Affairs, Medical Affairs & compliant Handling Unit in JJMS, local Regulatory Affairs and R&D to ensure the reporting to health authority are completed in time and in parallelly
Maintain and report appropriate Quality business measurements consistent with the Quality and Compliance dashboards to continually monitor the performance and roll up to Quality Progress Report and Quality System Management Review
Participate in the internal audit program as qualified internal Lead Auditor
Facilitate CAPA Review Board and provide training to promote the CAPA awareness within the organization
Prepare Quality Progress Report and Management Review meeting, and identify related actions with the review team and follow up with individuals to close all actions
In connection with other departments in and outside JJMSZ to guarantee quality and compliance to support all business objectives
Perform routine data trending analysis when necessary. Identify opportunities to improve Quality, present recommendation and coordinate implementation as applicable
Support all quality inspections (e.g. CFDA, FDA, Notified Body, JJRC, etc…)
Education and Work experience:
?Bachelor degree with over 8 years’ experience in quality management is a must
?Experience working in medical device and/or pharma with CFDA, FDA and European regulatory environment is preferred
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