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QA Manager

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職位描述

>>>Location:Shanghai


【Responsibilities】

·Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled;

·Perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination;

·Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs;

·Implementing and maintaining the QMS to ensure that required processes are established and effective;

·Process owner of quality systems such as, but not limited to; internal audits/self inspection, change control, management reviews, deviation management and CAPA;

·Compile and update training manuals, undertake induction training and refresher training related to QMS for local staff;

·Ensure quality agreements are established with 3rd parties;

·Ensure 3rd parties are qualified and maintained in an approved audit status;

·Decision of disposition for trade returns and damaged products;

·Maintenance, analysis and reporting of Quality KPIs;

·Develop and manage effective working relationships with competent authority and Global colleagues;

·Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary;

·Represent the company in the relevant committees of the professional/industry associations, if necessary.


【Qualification】

Education/Training :
·Bachelor’s degree or above major in life sciences disciplines.

Work Experience :
·Must be trained in or have experience with the requirement of medical device GSP at least for 5 years;
·Certificate on ISO 13485 will be preferred;
·Medical Device GMP experience will be preferred;
·Good understanding of Quality System regulations and requirements and ability to identify opportunity for improvement and implement improvement on the existing system.

Required pre-requisites skills/experience for this position :
·Strong organization, communication and teamwork skills to be able to effectively interact within multidisciplinary groups;
·Reliable,hardworking with enthusiastic and positive attitude;
·Good knowledge of Microsoft Office Tools;
·Fluent English (oral & writing).


Behavioural Skills \行為技能:
·Achievement;
·Customer and Brand Focus;
·Impact and Influence;
·Cooperation;
·Courage and integrity;
·Initiative and Anticipation;
·Innovation.


>>>Contact Information:
聯系人:Hailey Chen
聯系方式:15371491509(微信同號)
郵箱:[email protected]

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