武汉招聘

Principal Duties and Responsibilities

岗位职责

• Understand technical aspects of the job, best practices, and adhere to cGMP compliance.

      理解岗位技术要求、操作规范，确保cGMP符合性。

• Perform the Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).

      执行环境监测计划，包括系统执行、厂房确认、持续监测（取样、监测和趋势分析）

• Essential functions include but are not limited to: Bioburden Analysis, Endotoxin Analysis, Viable and Non-Viable Air sampling and analysis, Surface and Personnel monitoring and analysis, water system sampling and analysis.

      主要职责包括但不限于：微生物负荷分析、内毒素分析、浮游菌/沉降菌和尘埃粒子分析，表面和人员监控和分析，水系统取样       和分析。

• Determining the acceptability of test results and data generated from routine monitoring of clean rooms or technical studies, and the dissemination of these results.

       确认检测结果以及洁净区或技术研究日常结果是否可接受，以及结果分发。

• Shipping samples to approved contract labs for microbiological enumeration, identification, sterility and other tests.

       将样品发运至批准的合同实验室， 进行微生物计数、鉴别、无菌检查和其他检测。

• Training members of the department and other departments as necessary.

      培训部门成员或其他部门

• Develop and implement all necessary SOPs.

      起草SOP并执行所有相关SOP。

• Any other tasks as assigned by the supervisor.

      主管安排的其他工作。

Job Requirements

岗位要求

• High diploma’s degree or above in a pharmaceutical, chemical or biological discipline.

    药学、化学或生物学专业大专或以上学历。

• Strong background in standard and specialized methodologies for biologics products preferred.

       ***有生物制品检测背景知识。

• Thorough knowledge of GMP regulations and documentation.

      了解GMP法规和文件。

• Understanding of the basic statistics required in data analysis.

      了解基本数据分析统计学知识。

• Preferably with excellent oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents.

       ***有良好的英文和普通话口头和书面沟通能力 (听、写和说)，可以与其他职能部门和管理层沟通解决调查或理论问题，可以        起草技术文件。

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。