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符合QA(J24472)

WuXi AppTec · 江苏省·无锡市

External listingFull-time28 days ago

About The Role

  • 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.

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