武汉招聘

Job Responsibilities/岗位职责

1. Participate in the daily activities of the QA Department as assigned;
2. 质量检查部门的日常活动；
3. Work as directed to establish and maintain Quality Systems to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements;
4. 要求进行工作，以建立和维护质量体系以确保生产，测试和销售过程古河适用的法规要求；
5. Participate in the execution of the Product Complaint System and assist with product return, withdrawal or recall   activities, as needed;
6. 产品投诉系统的执行，并根据需要协助产品退货、撤回或召回；
7. Maintain compliance of the Environmental Monitoring and Validation programs, participate in the internal auditing program for company, as required;
8. 环境监测与验证计划的合规性,根据需要参加公司内部的审计计划；
9. Create and revise Quality Assurance related documents in support of GMP; Provide QA input on GMP Facility and GMP Utilities issues such as qualification/ requalification, changes, maintenance, startups/ shutdown, disaster recovery, etc.
10. 和修订与质量保证相关的文件以支持GMP; 提供有关GMP设施和GMP程序问题的质量检查输入，例如资格/变更资格、变革、维护、启动/关闭，灾难恢复等；
11. Review and approval of data for determining the disposition of GMP material (raw material, in？ process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the Stability Program;
12. 和批准用于确定GMP材料（原材料、加工、原料药、成品、包装、标签和生产组建）处置的数据，并审核和批准与稳定计划相关的文件和数据；
13. Assist QA Document Control in managing the CAPA, Discrepancy and Change Control systems;
14. 质量检查文档控制管理CAPA，差异和变更控制系统。
15. Assist in hosting regulatory, customer or due diligence inspections. Work closely with all departments, as assigned, to ensure timely responses and follow up of any observations;
16. 进行监管，客户或尽职调查，与分配的所有部门紧密合作，以确保及时作出相应并跟踪所有观察结果；
17. Identify training needs and organize training interventions to meet quality standards;
18. 培训需求并组织培训干预，以达到质量标准；
19. Other work arranged by superior leaders;
20. 领导安排的其他工作。

Job Requirements/岗位要求

1. BS degree, scientific discipline preferred;
2. 及以上学历，科学学科为佳；
3. 2-5 years’ experience in a Quality regulated industry, pharmaceutical or medical device experience is preferred. Experience in the biosimilar quality environment is a plus;
4. 两到五年质量监管行业工作经验，具有制药或医疗设备经验，具有生物仿制药质量环境经验者优先考虑；
5. In-depth knowledge of GMPs and related guidelines and regulatory requirements;
6. span>GMP及相关指导原则和法规要求有深入了解；
7. Proficiency in the use of Microsoft Office Applications;
8. 使用办公软件；
9. Must be self-motivated with ability to independently handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines;
10. 自我激励能力，能够独立处理、组织和确定多项任务时的优先级，并具抗压性；
11. Good oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within Quality Assurance and multi-disciplinary teams.

12.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。

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。