Process Expert
NTO SOLIDS
Beijing, China
17天前

Job Purpose :

Provide front line expert support for all process-specific issues including process / cleaning validation to production to ensure execution of processes on-

time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.

为工艺相关的所有事项包括工艺和清洁验证提供专业的一线支持 确保工艺按时执 行 质量和效率的不断提高 并符合现行GMP SOP和法律法规的要求

Major Accountabilities

  • Shop floor support : 一线支持 Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
  • 为生产提供一线支持 与生产倒班团队合作确保生产按时 安全 并符合每批的文 件指导和质量要求

  • Assist / organize the process / cleaning validation, design the protocol and write the report. Ensure that the process / cleaning validation activities and the documentation comply with the requirement of cGMP and the regulatory expectations in Production under the guidance of the QA.
  • 协助 / 组织制程工艺 / 清洁验证 设计验证草案 起草验证报告 在QA的指导下 确 保生产部门工艺 / 清洁验证行动及其记录符合当前GMP及监管预期

  • Annual Product Reviews and Product Quality Reviews : 年度产品回顾和 产品质量回顾 Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations.
  • 高度熟悉产品和工艺的各项趋势 为年度产品回顾和产品质量回顾提供信息 分析 并推动工艺技术方面的创新 Be a resource to other departments as Subject Matter Expert for the product and process knowledge. 作为产品和工艺知识方面的专家

  • Assist IQ / OQ / PQ. 协助IQ / OQ / PQ
  • Quick responsiveness to processing and packaging issues. 快速响应制程和包装工艺问题
  • Resolve processing / packaging issues (quality, safety or other regulatory) and improve process (product). 解决制程 / 包装工艺问题 质量 安全或其他调整 并且改进产品工艺
  • Solicit ideas for improvements. 搜集改进建议
  • Provide training as required. 根据需求提供培训
  • Lead and support deviation / complaint / OOS / OOE investigations and documentation in relevant system. 在相关系统中 支持偏差 / 投诉 / 超出说明 / 超出预期的调查及文件记录
  • Implement solutions for problematic processes. 执行问题工艺的解决方法
  • Support improvement for line efficiencies. 支持改进生产线效率
  • Support for product transfers and launches. 推动产品转移及投产
  • Develop and write SOPs for the processing. 改进和编写制程相关SOP
  • Support to prepare the URS for new processing equipment. 为新制程设备的用户需求标准 URS 的准备提供支持
  • 学士以上学位

    Fluent in spoken, written, listen and read English and Chinese

    英文和中文听说读写流利

    Minimum 3 years experience in the production field in Pharmaceutical industry, JV experience has priority.

    至少3年制药行业生产领域工作经验 有合资企业经验者优先

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