上海招聘

职位描述

1.1              遵守公司规章制度；

Obey the company regulations;

1.2              对生物新药研发流程有全面广泛的了解，熟知流程上的重要节点和所需重要数据；

Master Biologics drug discovery full process, understand the key experimental elements and data along the process;

1.3              负责生物新药早期研发阶段的QA流程撰写，更新，跟踪，确认及审核；

Be responsible for QA process drafting, updating, tracking, reviewing and confirming in drug discovery stage;

1.4              主持及领导各类现场核查（包括客户核查，FDA和NMPA等），参与各类异常事件的调查与审核；

Host all due diligence events from clients, FDA and NMPA, Participant in the investigation and review of quality events;

1.5              对研发实验记录进行控制和归档，定期检查新药研发过程中各项记录是否及时、规范、准确，确保数据完整性

Control and achieve all R&D lab notebook, timely review notebook and make sure the record timely, accurate and precise, integrated and traceable during drug discovery process.

1.6              负责追踪、学习国家新药研发的相关的政策、法规和管理制度，获得新药研发管理及相关法律法规和技术要求，对研发部门进行培训管理，确保研发质量体系符合要求；监督质量管理体系自检，确保其有效运行；

Be responsible for tracking and learning related government policy, legal guidance and management rules on drug discovery, understand drug discovery related management and techniques requirements, and be responsible for training department associates to ensure department QA system well established and followed.

1.7              负责QA功能组相关文件的起草，修订和审核；负责相关联部门文件的审核；组织研发人员进行研发方案制定，并对报告进行审核

Be responsible for the drafting, revising and review of relevant documents of QA function in BID department ;

Be responsible for the reviewing of relevant documents of other related function groups;

1.8              负责部门各类实验，检验记录的审核；负责质量标准、CoA等质量文件的审核；

Be responsible for reviewing of all assay records and testing records; Be responsible for reviewing specification and CoA quality documents.

1.9              协助制定内部抽检计划，参与内审和外部检查相关工作；

Assist to set up the internal audit plan, participate in internal and external audit;

1.10           协助公司合规工作，参与部门内部合规检查；

Assist with the compliance job of company and participle in checking of internal compliance;

1.11           定期向直接上级汇报工作情况；

Report to supervisor of job periodically;

1.12           完成上级领导交办的其它工作。

Finish the other jobs assigned by supervisor.

人员资质

1.1              具备医药或相关专业硕士以上教育背景，从事相关工作6年以上，熟悉新药研发阶段所必需的QA要求；

With the education background of medicine or relevant major of master or above, with more than 4 years related working experience, master the key QA requirements for drug discovery stage;

1.2              良好的组织管理能力，沟通协调能力；

Good management, communication and coordination skills；

1.3              上岗前各项考核（健康状况、培训）合格；

Pass the all examinations before onto job(healthy situation , training);

1.4              熟悉统计软件的使用；

Familiar with the usage of statistical software;

1.5              英语读写能力良好。

With good English reading and writing ability.

上海药明生物技术有限公司诚聘