Manufacturing QA Associate Manager 包装质量QA副经理

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

Quality Oversight / 质量监管

1.1 Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in repackaging products and IMP materials life cycle and the E2E process.

与质量利益相关方共同协作，利益相关方包括并不仅限于生产运营、供应商质量、质量系统及计划，在进口分包装产品及临床试验物料生命周期中端到端的过程实施质量监管。

As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation and packaging plants.

根据业务安排，监管区域应覆盖包括仓库运营和包装区域所有相关区域的质量活动。

Manage and oversee frontline QA activities of repackaging products and IMP products in plants.

管理进口分包装和临床试验产品的现场QA活动。

Manage of sampling process for repackaged products

管理对进口分包装产品抽样流程

Perform oversight of Specification, process and product monitoring for repackaging products

对进口分包装产品的质量标准，工艺与产品监测实施监督

Perform oversight of stability program for repackaging products

对进口分包装产品的稳定性项目实施监督

Connection with Global, take role as quality role across the repackaging product life-cycle management.

与总部联系，在进口分包装产品生命周期管理中做好质量角色

Execution of frontline QA activities in plants and warehouse

执行车间和仓库的现场QA活动

Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action.

根据生产计划，实时了解生产动态, 对实际生产情况与生产计划的偏离进行现场跟进，辨识潜在的质量风险，进行提前预防.

Join Tier meeting in production and warehouse or other Tier meetings

参加生产部和仓库例会或其他层级会议

Perform batch record review

执行批次记录审核

Enabling real-time problem solving with production and warehouse team

促进与生产和仓库团队共同实时解决问题

1.2    Implement repackaging and additional labeling IMP product-related batch release process

对进口分包装产品和临床试验药品重贴标的批次放行相关流程实施

Ensure on-time batch documentation review per the requirement of Roche Timeline.

确保按照罗氏时限要求及时执行批文件审核。

Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant

确保每批商业产品的生产受控、满足上市许可及其它法规要求，在经QP/AP放行前不得被销售

Additional labeling IMP batch release.

对IMP重贴标批次实施放行

1.3    Execution of direct/ IMPmaterials management

对直接/IMP物料执行QA质量监管

Ensure on-time direct material batch disposition per Roche requirement

确保按照罗氏要求及时执行直接物料批处置

Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc.

对物料质量实施监管，包含质量标准、Artwork、SAP/MES系统主数据、变更、偏差/CAPA、新物料确认及质量管理等。

Support local supplier quality management including audit, Quality Agreement etc.

支持本地供应商的管理，包括审计、质量协议等。

Clinical trial material shipping documents check and system release
负责临床试验物料的运输放行相关文件的核查和系统放行操作

Temperature excursion evaluation during transportation for local sourced IMPs.
负责本地罗氏临床试验药品在运输过程中的超温评估

Support the investigation of repackaging and IMP products complaints.
支持进口分包装产品和IMP相关投诉的调查

1.4    Coordination and handling for quality related issue / 质量相关事件的协调与处理

Implement the management of Event &CAPA：Be able to utilize RCA tools and can facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release.

实施事件及纠正及预防措施管理：能够运用根本原因分析工具，协调各部门进行偏差调查，确保偏差调查在规定时限内完成，支持产品放行。

Collaborate with SMEs and Lead investigators to develop investigation strategies

与调查领导者及相关SME协作，制定调查策略

Participate in Local Quality Council when needed

在需要时，参与本地质量委员会

Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time  and keep continuous improvement
监控调查进程以确保有效的纠正及预防措施及时发起并实施并持续改进

Handle Customer complaint:

客户投诉处理

Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time

与相关部门完成客户投诉调查进程以确保有效的纠正及预防措施及时发起并实施

1.5    Quality system oversight/ 质量体系的监管

Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections

执行QA 流程/文件的维护以确保质量保证流程/文件处于持续合规状态，并保持可随时接受监管机构检查的状态。

Manage material quality management in site

管理工厂范围内的物料质量管理

Manage repackaging of finished products and labeling management for donation products.

管理成品的重包装及捐赠产品的贴标管理。

1.6    Other quality related activities / 其他质量相关活动

Support to draft and review the local product APQR.

支持起草并审核年度产品质量回顾

Involve and support the inspection by HA and Roche Global inspection.

支持对工厂的官方与罗氏总部的审计

Involve quality related projects.

参与质量相关的项目

Document management

文档管理

1.7    Complete other tasks assigned by senior leaders

完成上级领导交办的其他任务

Key Interfaces / 主要交界面:

Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs

生产、工程、本地MSAT、计划、仓贮、安全、医学部和法规事务

Other Quality Functions

其它质量职能部门

QMS document owners/authors

QMS文件负责人/作者

Global Functions: Regulatory (PDR/PTR), PT Development, TPLs and GxP Supplier Management.

全球职能：注册（PDR/PTR）、技术运营部发展、TPLs和GxP供应商管理。

Education/Qualifications / 教育背景/任职资格

Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)
本科学历（药学、制药、生物工程、化学等相关专业，四年制本科教育或同等教育水平）。

Graduate or higher-level Degree is preferred
硕士及以上学位者优先。

Job Required Competencies / 岗位所需能力

Good accountability of GMP understanding and implementing.
能够充分理解并有效执行药品生产质量管理规范（GMP），具有良好的责任意识。

Knowledge and experience in production and quality management.
具备生产管理和质量管理方面的知识与经验。

Well communication skill and good accountability of problem solving.
具备良好的沟通能力，能够主动承担解决问题的责任。

Demonstrate good verbal and written communication skills in English
具备良好的英语口头及书面沟通能力。

Focus on value and customer
关注价值创造，以客户为中心。

Learn for the future
面向未来，持续学习。

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.