符合QA(J24472)

负责药品生产许可证，GMP证书等的生命周期维护，包括变更和续期。 Maintain lifecycle of drug manufacturing license, GMP Certificates, etc., including changes and renewal. 持续跟踪国内外GMP法规和指南的更新，维护GMP法规清单。 Continuously monitor updates to domestic and international GMP regulations and guidelines. Maintain the GMP regulation list. 负责对客户的产品注册、申报提供支持。 Be responsible for providing support to clients on filing/registration/PAI. 负责审计前的准备，审计中的协调，以及审计后的回复和CAPA跟进。 Be responsible for preparation, coordination, and response to regulatory inspection, client audit and internal audit, as well as CAPAs follow-up. 负责在客户审计及法规审计中，对质量管理体系的问题进行解答及回复。 Be responsible for acting as front person to present general QMS during client audit or regulatory inspection. 参与质量管理体系文件的起草和审核。 Mainly participated in drafting and reviewing the QMS documents. 参与推动偏差调查、变更和CAPA的有效执行和记录。 Mainly participated in Coordinating deviation investigation, change control and CAPAs to ensure the effective execution and record of the them. 完成主管安排的其他工作和任务。 Any jobs and responsibilities assigned by the supervisor.

本科及以上 Bachelor degree or above 化学、药学、制药学，或相关化学专业 Chemistry, pharmaceutical, or equivalent experience 良好的普通话/英语的书写/口语交流能力 Good writing/communication skill in Mandarin/English 熟悉MSOffice等办公软件，及趋势分析相关工具 Familiar with MSOffice and other office software, and tools for trend analysis 需具有至少3年以上，制药行业GMP质量体系符合性相关工作经验 Should have more than 3 years of working experience on GMP quality system compliance in pharmaceutical industry 具有中国药监局，FDA，欧盟GMP法规知识和经验 Must have experience on NMPA, FDA, EMEA GMP regulation. 具有多年质量体系管理相关工作经验 Must have experience on QMS management. 具备识别风险/不合规的能力，预防风险的管理和沟通能力 Skills for risk/non-compliance identification and proactive risk management and communication. 能够与来自多元化文化氛围的其他人员合作，积极主动、主导和高效的工作，比如，与跨部门的合作和自我指导的工作 Proven ability to motivate, mentor and work efficiently, with persons from other cultures, as in cross-functional and self-directed work teams 能够在一定的压力下工作，在规定的时间交付工作 Be able to work under pressure and deliver work timely.