Senior SpecialistAssociate Manager ASAT

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

Implement GMP compliance with global GMP standards and China GMP requirement

根据总部和中国 GMP要求执行 GMP符合性工作

Sample receipt storage distribution and disposal procedure management.

样品的接收存储分发及处理流程的管理

Reference and retention sample management.

参考留样及常规留样的管理

Excute analytical transfers and local analytical method verifications.

执行分析方法转移和本地分析方法确认

Ensure process and cleaning validation analysis execution.

确保工艺验证和清洁验证的执行

Maintenance of QC specifications and analytical methods.

维护 QC的质量标准和分析方法

Packaging material standard sample management.

包材的标准样管理

Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reports

维护验证主计划及时执行方法验证计划和报告

Third party QC labs management

第三方实验室管理

Provide technical guidance on test methods and relevant procedures.

对测试方法和检测过程提供技术支持

Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing.

确保支持生产过程中的故障排除和其他的产品生命周期测试

Manage the trending process in labs according to Roche PQS requirements and regulations

根据罗氏 PQS和法规要求管理实验室的趋势分析流程

Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods.

确保 QC的质量标准和分析方法和 CMC注册文件一致

Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirements 确保 QC的质量标准和分析方法符合相关药典要求

Support Chinese Pharmacopeia commenting and implementation across the network

支持中国药典在集团内的意见反馈与执行

Stability program - chamber management coordination with global and laboratories for timely execution of stability protocols and stability report stability trending

稳定性安排-箱子管理协调总部和实验室以保证稳定性方案报告以及稳定性趋势分析的及时执行

QC metrics generation and report managing performance of quality system processes (TCM

Discrepancies CAPA etc) for QC

QC量度的生成及报告管理 QC相关的质量体系变更偏差CAPA等的指标

Reference standards management

标准品管理

Provide QC technical support and oversight to CMO activities

对 CMO活动提供 QC技术支持和监督

Support regulatory inspections and partner audits

支持官方审计和合作伙伴审计

Education/Qualifications教育程度/所获资格证书

Bachelors Degree((biology microbiology biochemistry chemistry or other relevant discipline is preferred) 学士学位 ( 生物微生物生物化学化学及相关学科优先)

Graduate or higher-level Degree is preferred

更高学历优先

Leadership Competencies领导力

At least 3 years experience in analytical/or technical registration area of pharmaceutical industry

至少 3 年在制药企业分析或技术注册领域工作经验

Job Required Competencies岗位所需胜任力

Expert knowledge of compendial test methods (e.g. ChP USP EP JP) for Pharmaceutical Industry

制药行业药典方法例如 ChPUSPEPJPcGMP的专业知识

Relevant CMC regulation and cGMP knowledge of the pharmaceutical industry

制药行业相关的注册法规和 cGMP知识

Relevant knowledge of Quality System principles practices and standards for the pharmaceutical industry 制药行业质量体系原则实践和标准的相关知识

Demonstrate excellent verbal and written communication skills in English

表现出良好的英语口语和书面沟通能力

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.