Senior Specialist - Production Process Support 生产流程支持高级专员

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Principle Roles & Responsibilities / Accountabilities 主要职责/责任

Support GMP activities in Production

支持生产部GMP活动

• Assist Superior in the Production Department to deal with quality problem on site

协助生产主管协助处理产品质量问题

• Support the Production to solve the deviation/complaints, make proper mitigation action to solve the problem

支持生产部的偏差处理及投诉并通过制定合适的补救措施来解决问题

• Supporting the QRM activities within Production, overview the E2E risk management for each product.

支持生产部质量风险评估的相关行动,确保每个产品端到端的风险管理。

• Supporting the CAPA, Change Control management within Production

支持生产部的CAPA,变更管理

Responsible for document management for technical/GMP relevant general documentations within Production to ensure compliance with internal and external regulatory requirements.

负责生产部内部产品技术和GMP相关的通用文件管理，确保符合内外部法规要求

• Taking ownership of management for general sops within production

负责生产部通用sop的管理

• Develop/maintain the general management procedure for all the documentation (GMP related & business related)

建议和维护文件管理的通用流程(GMP相关及业务相关)

As PTSH Data Integrity Stewards, promote data integrity work of production related system and equipment.

作为上海工厂数据可靠性管理员，推进生产部相关系统及设备的数据可靠性工作

• Working closely and collaborate with DI Site Lead on Site Data Integrity Assurance Management, push the Data Integrity Strategy and approach actively, ensure to comply with global PQS requirements and local regulatory.

与工厂数据可靠性负责人就工厂数据可靠性管理紧密合作，积极推进工厂的数据可靠性改进项目，确保符合全球PQS以及法规的要求。

• Serve as the site Data Integrity SME, provide technical guidance of Data Integrity Assurance procedures to relevant stakeholders and develop and for your department.

作为工厂数据可靠性主题专家，向部门内的相关人员提供有关数据可靠性保证流程的技术性支持。

• Review/Approve Assessment Reports (eg. DI Risk Assessment, Audit Trail Review Assessment) for Data Integrity for your department.

审核或批准部门内DI相关的评估报告（例如数据可靠性风险评估，审计追踪审核评估）。

• Organize and engage as part of Site DI Gemba Walk, include leadership team Gemba Walk and routine department DI Gemba Walk as need.

根据需要，组织部门Routine DI Gemba并积极参与工厂Leadership team DI Gemba。

• Support Data Integrity Site Lead to perform Site DI Maturity Assessment

支持数据可靠性工厂负责人进行工厂的数据可靠性成熟度评分。

Supporting the global GMP documents implementation within production

支持全球GMP文件在生产部的实施

• Coordinate with Q union to have an overview of new global GMP documents published condition.

与质量部门合作，概览全球GMP文件在生产部的实施。

• Review the local SOPs which were updated according to relevant GSPs to ensure the local SOPs were aligned with global GMP documents.

对本地SOP进行审核，以确保与相应全球GMP文件的一致性。

Qualification and Experience 能力与经验 

Education/Qualifications教育程度/所获资格证书

University or above

本科及以上

Pharmacy, Chemistry, Biochemistry and equivalent

药学、化学、生物化学及相关学科

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

5 Years work experience in quality assurance or equivalent

五年质量保证及相关工作经验

At least 5 year experience of technical position in pharmaceutical company manufacturing.

至少五年药厂技术岗位工作经验

Expertise in the using of PMP & lean tools is preferred

能够熟练运用项目管理和精益生产工具更好

l  Knowledge of GMP

GMP知识

l  Skills and experience of pharmaceutical production process and in-process control

制药生产过程和现场控制经验和技能

l  Technical documentation writing skill

技术文件书写能力

l  Knowledge of Quality management

质量管理知识

l  Leadership skill

团队管理能力

l  Language skill: Good at English, listening, speaking, reading and writing.

语言技能:  具有良好的英语听说读写能力

l  PC skill: Office, Minitab(or equivalent software)

电脑技能:  Office, Minitab(or equivalent software)

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.