上海招聘

职位描述：
QA auditor will work with technical area representatives, laboratory management and quality team. The primary responsibilities are reviewing laboratory records and raw data, supporting the maintenance and integration activities related to the laboratory’s quality system, hosting internal inspection, vendor/contractor audits, regulatory audits and identifying implementation of continuous improvement.

1、Review laboratory records to assess the compliance to the SOPs and the project protocol if applicable.
2、Make inspection plan and conduct the inspection on the lab operation to assess the compliance to the SOPs.
3、Manage vendor/contractor list and conduct vendor/contractor audit periodically. And audit the records generated by contractor.
4、Conduct compliance training to technical person.
5、Assist and advise QA management on quality system improvement.
6、Assist inspections by client or regulatory agency when necessary.
7、Perform all function of a document controller, change control, training controller, including, but not limited to the following:
      Maintaining/Controlling the documents used in the quality system;
      Maintaining training system including curricula vitae, job description, training plan, training records, etc;
      Maintaining CAPA database. 举报 分享

Huabo Biopharm Co., Ltd., a wholly owned subsidiary of Huahai Pharmaceutical, is a start-up biotech company dedicated to discovery, development, and commercializing of breakthrough therapies with the potential to deliver meaningful clinical benefit to tumor patients. We are currently advancing a pipeline of promising preclinical candidates and have robust research capabilities fuelling our long-term growth. To meet the fast advancement of project R&D, we are looking for two top managers who will fill the positions of chief scientific officer (CSO) and vice president (VP) respectively. The candidates should have solid background in cell biology, or antibody development, or cell line generation and cell line processing, and have comprehensive experiences in biological drug development in industrial area abroad.
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