SRD-0144406
v4.0

1. Position
Details职位基本信息：

Position
Title:

职位名称:

Quality Specialist

质量专员

Division:

部:

PT

技术运营部

Reports
to:

直接主管:

Head of SQM and
Quality Processes

供应商质量管理与质量流程负责人

Department:部门:

Quality

质量部

Functional
Manager:

(Global
Functions)

职能经理:

(全球职能部门)

N/A

Location:

工作地点:

HQ, Shanghai

上海总部

2.
Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）

Responsible for assisting in the management of supplier quality
management activities and quality processes

负责协助供应商质量管理活动和质量流程的管理。

Responsible for assisting in the business excellence of the Quality
department, including project management, communication, and event
organization.

负责协助质量部门的卓越运营，包括项目管理、沟通及活动组织等。

3.
Principle Roles & Responsibilities / Accountabilities 主要职责/责任

(Major functions of the position)
（职位的首要职能）

l
SQM and Quality Processes /供应商质量管理与质量流程

Assist in providing
quality and compliance oversight for external GxP suppliers to ensure
compliance with cGMP and Quality Agreement requirements.

协助进行外部GxP供应商提供质量和合规监督，以确保符合cGMP和质量协议的要求。

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.

协助负责质量风险管理（QRM），确保符合相关GMP/GSP法规和罗氏集团标准的要求，对中国技术部运行的QRM流程进行良好维护。

Assist in monitoring
Quality metrics, organizing Quality Council and Management Review of Quality,
and etc.

协助质量指标监控，组织质量委员会和质量体系的管理评审等。

Support China
compliance activities, policy advocacy topics, related working groups and
external interactions.

支持中国区的合规活动，政策倡导话题，相关工作组和外部互动。

l
Quality Business Excellence/质量部卓越运营

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..

协助质量部项目管理相关工作（如项目经理培训，进度跟踪，定期项目状态更新），协调并支持各项目的成功交付。

Support
organizing Quality department activities, including team-building activities,
training sharing sessions, workshops, and Townhalls.

协助组织质量部活动，包括团队建设活动、培训分享会、研讨会和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.

协助质量部的沟通与宣传工作，包括质量部新闻期刊组织与撰写、内外部奖项申请等。

4. Qualification and Experience 能力与经验

Education/Qualifications教育程度/所获资格证书

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

学士学位；更高学位优先。

Pharmaceutical,
Chemistry, Biochemistry, Bio-engineering or relevant disciplines.

药学，化学，生物化学，生物工程或相关学科。

Leadership Competencies领导力

• Models
  Integrity倡导诚信


• Focus on
  value and customer价值与客户导向


• Align for
  success协力成功


• Deliver
  results结果导向


• Learn for
  the future不断学习

Job
Required Competencies岗位所需胜任力

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

具备良好的制药行业质量系统和合规理念、实践和标准的良好知识。

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

具备良好的制药行业cGMP相关的知识，了解当地和国际GMP规定。

• Good
  Learning & Adaptability.

良好的学习与适应能力。

• Good
  Teamwork & Collaboration

良好的团队协作精神

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

良好的沟通，分析与解决问题的能力。

• Good
  Accountability and Proactiveness

良好的责任心与主动性。

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

良好的英语听说读写能力。

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

良好的办公软件运用：Word，Excel，PowerPoint, AI。

5. Change History /历史记录

Version

Changes

1.0

New Created JD.

新建JD。