質(zhì)量專員

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(yùn)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(fù)責(zé)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
上海總部

2.
Primary Purpose of Job (Job Summary)主要工作目標(biāo)（崗位簡介）

Responsible for assisting in the management of supplier quality
management activities and quality processes
負(fù)責(zé)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(fù)責(zé)協(xié)助質(zhì)量部門的卓越運(yùn)營，包括項目管理、溝通及活動組織等。

3.
Principle Roles & Responsibilities / Accountabilities 主要職責(zé)/責(zé)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(jìn)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(fù)責(zé)質(zhì)量風(fēng)險管理（QRM），確保符合相關(guān)GMP/GSP法規(guī)和羅氏集團(tuán)標(biāo)準(zhǔn)的要求，對中國技術(shù)部運(yùn)行的QRM流程進(jìn)行良好維護(hù)。
Assist in monitoring
Quality metrics, organizing Quality Council and Management Review of Quality,
and etc.
協(xié)助質(zhì)量指標(biāo)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(yùn)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(jìn)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(tuán)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(xué)士學(xué)位；更高學(xué)位優(yōu)先。
Pharmaceutical,
Chemistry, Biochemistry, Bio-engineering or relevant disciplines.
藥學(xué)，化學(xué)，生物化學(xué)，生物工程或相關(guān)學(xué)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(xué)習(xí)

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(biāo)準(zhǔn)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(dāng)?shù)睾蛧HGMP規(guī)定。

• Good
  Learning & Adaptability.

良好的學(xué)習(xí)與適應(yīng)能力。

• Good
  Teamwork & Collaboration

良好的團(tuán)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(zé)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(yùn)用：Word，Excel，PowerPoint, AI。

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