Opportunity Description
主要职责/Key Responsibilities：
1. 管理公司适用过程的文件体系和要求。确保所有 QA 文件都符合事业部、集团和监管规定的要求，并且为当前最新版本。Manage the documentation system and requirements for assigned operations.Ensure all QA documents meet established divisional, corporate and regulatory requirements, and are current and up to date.
2. 识别文件体系中的任何差距，并采取必要的措施来纠正和改进。Identifies any gaps in the documentation system and take necessary actions tocorrect and improve. Develop and improve on the documentation routing process to assure timely implementation of requested changes.
3. 支持内/外部审核的审核准备工作，包括培训员工/指导审核的准备工作。Support Audit Readiness activities for internal/external audits including training staff / guidance in preparation of the audits.
4. 负责内/外部审核改进的跟踪和关闭。Responsible for tracking and closure of internal and external audit improvements
5. 根据既定程序，负责协助定期进行各类指标统计和报告。Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
6. 参与或主导CAPA项...