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Job Summary職位概述:
1.
Responsible
for maintaining and updating the quality system, working procedure, to monitor the
implementation and documentation, to ensure the compliance with local and
global regulations.
負責維護更新質(zhì)量管理制度、工作程序，并監(jiān)控其實施及記錄情況，確保符合當?shù)睾图瘓F政策。
2.
Fulfill
the company SOPs, regulatory and quality control.
執(zhí)行公司質(zhì)量管理規(guī)定進行質(zhì)量法規(guī)控制工作。
3.
Complete
tasks as required and be able to provide comments and feedback in the process.
按要求完成任務(wù)并能在過程中提出意見和反饋。
4.
Participate
in cross-functional, regulatory, industry association, etc. projects, and be
able to provide feedback and suggestions.
參加公司內(nèi)跨部門、監(jiān)管機構(gòu)、行業(yè)協(xié)會等的項目，能提出反饋和建議。
5.
Solve
daily problems based on existing processes and regulatory requirements.
基于現(xiàn)有的流程及法規(guī)要求解決日常問題。
6.
This role
serves as a key quality
and safety post.
該崗位作為質(zhì)量安全關(guān)鍵崗位。

Main Tasks & Responsibilities主要工作職責 :

1.
Be responsible for
quality assurance activities of the company, including support product
development team with design and development activities in compliance with
applicable regulatory，standards and design
control processes in product lifecycle, provide product development team
coaching or training with applicable regulation, standards and processes, guide
development team during product development planning, review and approve design
and development deliverables, review and approve product changes, etc.
負責公司產(chǎn)品質(zhì)量保證活動，包括在產(chǎn)品生命周期中支持產(chǎn)品開發(fā)團隊開展符合適用法規(guī)、標準要求與設(shè)計控制流程要求的設(shè)計開發(fā)活動，為產(chǎn)品開發(fā)團隊提供設(shè)計控制流程、適用醫(yī)療器械法規(guī)、標準的咨詢或培訓，
指導開發(fā)團隊進行產(chǎn)品開發(fā)過程定義與策劃， 審核設(shè)計開發(fā)交付件， 評審、批準產(chǎn)品變更等。
2.
Participated in the review of deliverables of the localized product
during production transfer process at each stage and relevant activities, to ensure that the deliverables comply with Roche
headquarters and local quality regulations and meet the company's business
needs.
參與本地化產(chǎn)品生產(chǎn)轉(zhuǎn)移過程中各階段交付成果的評審以及相關(guān)活動，確保交付成果符合羅氏總部及當?shù)氐馁|(zhì)量法規(guī)要求，并符合公司業(yè)務(wù)需求。
3.
Participate
in quality management activities during the product life cycle of the MAH and software products, including product
change management, quality monitoring with entrusted manufacturing companies,
product release and review and closure of NC/CAPA/SCAR, etc.
參與注冊人制度產(chǎn)品和獨立軟件產(chǎn)品生命周期內(nèi)的質(zhì)量管理活動，主要包括產(chǎn)品變更管理，對受托生產(chǎn)企業(yè)的質(zhì)量監(jiān)控，產(chǎn)品上市放行及NC/CAPA/SCAR的評審和關(guān)閉等。
4.
Communicate, train
and monitor local implementation of applicable local regulatory requirements
and global Standards，and assist in the
establishment and maintenance of GMP-related quality systems.
溝通、培訓、監(jiān)測本地法規(guī)和總部質(zhì)量標準在當?shù)氐膱?zhí)行并協(xié)助GMP相關(guān)質(zhì)量體系的建立和維護工作。
5.
Quality
Documents & Records Control and Change Control. Keep records. Have clear
filing and maintenance of all documents.
質(zhì)量文件、記錄的控制及變更文件的控制。文件分類歸檔，保留完好。
6.
Coordinate
and support for External Audit, Internal Audit.
協(xié)調(diào)及支持完成公司內(nèi)部及外部的質(zhì)量方面的審核工作。
7.
Conduct
business in full compliance including but not limited to Roche Secure, Roche
Behavior in Business, Roche Competition Law Interactive Dialogues, Roche
Safety, Security Health and Environmental Protection.
遵循羅氏所有合規(guī)要求，包括但不限于羅氏信息安全，羅氏商業(yè)中的行為，羅氏競爭法互動對話，羅氏安全健康環(huán)境等，合法合理開展業(yè)務(wù)活動。
8.
Understand
and fulfill the responsibility of line manager's SHE tasks and duties (as
defined in SHE handbook).
了解并執(zhí)行直線經(jīng)理的SHE職責（詳見SHE手冊相關(guān)定義）。