Senior Analyst, Microbiology and EM Lab, SRPL

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.

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Routine Operation:

• Performance of microbiological testing including Microbial limit test Endotoxin and sterility test of product stream samples (excipients bulk packaging materials and finished products) to meet product release timelines.
• 执行产品流样品辅料半成品包材和成品的微生物测试包括微生物限度细菌内毒素以及无菌检查以满足产品放行计划
• Performance of environmental and critical utility testing in accordance with Chinese GMP EU GMP and cGMP regulations and Roche/Genentech standards.
• 根据中国GMP欧盟GMP美国cGMP法规和罗氏/基因泰克的标准进行环境监控和关键设施的测试
• Performance of microbiological testing of stability samples to meet stability program requirements.
• 执行稳定性样品的微生物测试以满足稳定性研究计划的要求
• Supporting manufacturing operations by timely completion of direct material sampling and ID testing.
• 及时完成直接物料的取样及鉴别测试以支持生产运营
• Qualification and validation of microbiological test methods.
• 微生物测试方法的确认与验证
• Accomplish the calibration and maintenance of assigned instruments to ensure they are in good order to meet the analytical needs any time.
• 完成指定仪器的校准与维护确保其处于良好状态以随时满足分析需求
• Maintain laboratory cleanliness and inventory of microbiology supplies
• 保持实验室清洁并维护微生物耗材库存
• Supports lean initiatives in the area of lab operations test method execution documentation updates and equipment qualification
• 支持实验室运营测试方法执行文件更新和设备验证等方面的精益项目
• Supporting investigations of microbial contamination in production processes classified environments and critical utility systems.
  支持在生产工艺洁净环境和关键设施系统中发生的微生物污染的调查

Qualification and Experience 能力与经验

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

Job Required Competencies岗位所需能力

• 6 or more years of QC experience with a focus on microbiology
• 拥有6年或以上的质量控制QC经验侧重于微生物领域
• Sound knowledge of quality control procedures and legal standards with experience in microbiological testing.
• 熟悉质量控制程序和法规标准并具备微生物检测的经验
• Expert knowledge of cGMP relevant to the pharmaceutical industry
• 制药行业相关的cGMP知识
• Expert Knowledge in Pharmaceutical Microbiology
• 优异的制药微生物知识
• Fluent communications skills in English
• 流利的英语沟通能力

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.