世界500强药企项目助理
万宝盛华企业管理咨询(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:中介服务
职位信息
- 发布日期:2019-11-15
- 工作地点:上海-闵行区
- 招聘人数:1人
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:1-1.5万/月
- 职位类别:合规主管/专员
职位描述
Role Description
Position in the Scientific Operation team of Shanghai Discovery Center, mainly on supporting department training and quality compliance management, records and documentation archiving, and contracting process for 1 year on a renewable basis. Principle Responsibilities
· Act as the department Training Coordinator role
1) Develop department annual training plan
2) Ensure timely assignment and coordination of functional trainings for onboarding staff and ad hoc trainings for existing staff
3) Proactively monitor and follow up on mandatory training completion and CV/JD readiness in J&J online compliance system
4) Organize and archive department training records for inspection readiness
· Act as the department Records Coordinator role
1) Maintain and update J&J WWRIM required records retention information, including but not limited to Vital Records Inventory, Retention Schedules
2) Facilitate archiving of local SOPs, Work Instructions, Guidance, etc.
3) Manage and archive Handover Checklist for terminating and long-term leave staff
· Assist on Discovery Data Integrity (DDI) and electronic lab notebooks (ELN) compliance management (optional) 1) Conduct tailored ELN self-checks according to DDI requirements under supervision for deviation monitoring and escalate issues identified to line manager
2) Facilitate corrective behaviors from scientists with incompliant ELN recording habits
· Support Discovery Center contracting process
1) Facilitate department contracting process managed by the Scientific Operation team on essential system submissions required for contracting initiation and completion
2) Support contract sign off procedure
3) Maintain contract status tracker and online management system
4) Coordinate department external translation service requests especially for contracts Minimum Requirements · B.S., M.S., B.A. or M.A. degree
· Sensitive to aspects and requirements on compliance and quality in the drug discovery and development field
· Knowledge of pharmaceutical industry data generation and recording process is preferred, but not required
· Ability to manage projects and work independently, with good attributes of attention to details
· Good organizational and inter-personal skills
· Excellent computer skills in Microsoft Office application tools (e.g., Excel) and knowledge and use of database tools · Fluent in English and Chinese
职能类别:合规主管/专员
关键字:合规Compliance
公司介绍
联系方式
- Email:manpowerrecruiting@163.com
- 公司地址:华苑产业园海泰大道