SRD-0144406
v4.0
1. Position
Details職位基本信息：
Position
Title:
職位名稱:
Quality Specialist
質(zhì)量專員
Division:
部:
PT
技術(shù)運營部
Reports
to:
直接主管:
Head of SQM and
Quality Processes
供應(yīng)商質(zhì)量管理與質(zhì)量流程負責人
Department:部門:
Quality
質(zhì)量部
Functional
Manager:
(Global
Functions)
職能經(jīng)理:
(全球職能部門)
N/A
Location:
工作地點:
HQ, Shanghai
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2.
Primary Purpose of Job (Job Summary)主要工作目標（崗位簡介）

Responsible for assisting in the management of supplier quality
management activities and quality processes
負責協(xié)助供應(yīng)商質(zhì)量管理活動和質(zhì)量流程的管理。
Responsible for assisting in the business excellence of the Quality
department, including project management, communication, and event
organization.
負責協(xié)助質(zhì)量部門的卓越運營，包括項目管理、溝通及活動組織等。

3.
Principle Roles & Responsibilities / Accountabilities 主要職責/責任
(Major functions of the position)
（職位的首要職能）
l
SQM and Quality Processes /供應(yīng)商質(zhì)量管理與質(zhì)量流程
Assist in providing
quality and compliance oversight for external GxP suppliers to ensure
compliance with cGMP and Quality Agreement requirements.
協(xié)助進行外部GxP供應(yīng)商提供質(zhì)量和合規(guī)監(jiān)督，以確保符合cGMP和質(zhì)量協(xié)議的要求。
Assist in
Quality Risk Management, ensuring QRM process is well maintained for PT China
operations following the requirements of relevant GMP/GSP regulations and
Roche global standards.
協(xié)助負責質(zhì)量風險管理（QRM），確保符合相關(guān)GMP/GSP法規(guī)和羅氏集團標準的要求，對中國技術(shù)部運行的QRM流程進行良好維護。
Assist in monitoring
Quality metrics, organizing Quality Council and Management Review of Quality,
and etc.
協(xié)助質(zhì)量指標監(jiān)控，組織質(zhì)量委員會和質(zhì)量體系的管理評審等。
Support China
compliance activities, policy advocacy topics, related working groups and
external interactions.
支持中國區(qū)的合規(guī)活動，政策倡導(dǎo)話題，相關(guān)工作組和外部互動。

l
Quality Business Excellence/質(zhì)量部卓越運營
Support project
management-related work of the Quality department (such as project manager
training, progress tracking, regular project status updates), coordinate and
support the successful delivery of various projects..
協(xié)助質(zhì)量部項目管理相關(guān)工作（如項目經(jīng)理培訓(xùn)，進度跟蹤，定期項目狀態(tài)更新），協(xié)調(diào)并支持各項目的成功交付。
Support
organizing Quality department activities, including team-building activities,
training sharing sessions, workshops, and Townhalls.
協(xié)助組織質(zhì)量部活動，包括團隊建設(shè)活動、培訓(xùn)分享會、研討會和Townhall。
Support the
communication and publicity work of the Quality department, including the
organization and writing of quality department newsletters, and the
application for internal and external awards.
協(xié)助質(zhì)量部的溝通與宣傳工作，包括質(zhì)量部新聞期刊組織與撰寫、內(nèi)外部獎項申請等。

4. Qualification and Experience 能力與經(jīng)驗
Education/Qualifications教育程度/所獲資格證書

• Bachelor’s
  Degree required, graduate or higher-level Degree is preferred.

學士學位；更高學位優(yōu)先。
Pharmaceutical,
Chemistry, Biochemistry, Bio-engineering or relevant disciplines.
藥學，化學，生物化學，生物工程或相關(guān)學科。

Leadership Competencies領(lǐng)導(dǎo)力

• Models
  Integrity倡導(dǎo)誠信
• Focus on
  value and customer價值與客戶導(dǎo)向
• Align for
  success協(xié)力成功
• Deliver
  results結(jié)果導(dǎo)向
• Learn for
  the future不斷學習

Job
Required Competencies崗位所需勝任力

• Good
  knowledge of Quality System and Compliance principles, practices and
  standards for the pharmaceutical industry.

具備良好的制藥行業(yè)質(zhì)量系統(tǒng)和合規(guī)理念、實踐和標準的良好知識。

• Good
  knowledge of cGMP relevant to the pharmaceutical industry, knowledge of
  the local and international GMP regulations.

具備良好的制藥行業(yè)cGMP相關(guān)的知識，了解當?shù)睾蛧HGMP規(guī)定。

• Good
  Learning & Adaptability.

良好的學習與適應(yīng)能力。

• Good
  Teamwork & Collaboration

良好的團隊協(xié)作精神

• Well
  communication skill and good accountability of analytical and problem
  solving.

良好的溝通，分析與解決問題的能力。

• Good
  Accountability and Proactiveness

良好的責任心與主動性。

• Good at
  English, listening, speaking, reading and writing.

良好的英語聽說讀寫能力。

• Good at
  office software: Word, Excel, Power Point, AI.

良好的辦公軟件運用：Word，Excel，PowerPoint, AI。

5. Change History /歷史記錄
Version
Changes
1.0
New Created JD.
新建JD。