岗位描述
本科以上学历,生物学,药学,化学或其他相关专业
验。 Bachelor's degree or higher in Biology, Pharmacy, Chemistry, or a related field
较强的书面和口头沟通能力以及出色的人际交往能力。
Strong communication skills, both written and verbal, and outstanding interpersonal skills
可以熟练的阅读、撰写并且理解英文文档。 Be
skilled at reading, writing and understanding of English documentation.
良好的计算机操作技能,熟练使用Word、Excel、PowerPoint等
Good computer operation skill, intermediate level inMicrosoft Word, Excel, PowerPoint etc.
具有较强的组织,沟通,团队合作,高效执行,独立工作能
力。
Strong capability of organizing, communicating, team working, executing and
independently.
2. 工作职责 Job Responsibility
工作职责 Job Responsibility *
2.1负责生产或相关领域的SOP/OJT/TRA/QRA/MBR/FORM/PRT/MMRL等GMP文件的起草,升版和审阅。
Be responsible for manufacturing or related area document drafting, revising and reviewing,including SOP/OJT/TRA/QRA/MBR/ FORM /PRT/PFD or other documents. 2.2负责组织部门内部新员工培训以及部门内人员培训相关内容确认。
Be responsible for organizing new employee training and assure that training documents are followed.
2.3负责培训协调和跟踪并按时完成个人的培训任务,确保部门员工能及时完成其他部门提供的相关培训。
Be responsible for training coordination and
timely complete individual training tasks, ensure department staff can complete relevant training provided by other departments in a timely manner.
2.4撰写偏差、变更实行、纠正和预防措施、供应商投诉等质量事件的发起和评估调查。 Drafting and initiation, evaluation andinvestigation of quality events such as deviation investigation, change control, CAPA and supplier complaints.
2.5按时完成个人的培训任务,配合完成其他部门对其他有需求的员工进行相关培
训。
Timely complete individual training tasks, conduct training for employees in the otherdepartments as required.
2.6主导或参与生产体系的问题改进以及质量效率提升。
Lead or participate in problem improvement and quality efficiency improvement of production system.
2.7熟悉掌握相关工序,能严格遵守相关操作规程,必要时支持生产。 Familiar with mastering relevant procedures, strictly abide by relevant operating procedures, and support production
when necessary. .