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人才招募
Job Title: Formulation Engineer
Location: Suzhou

Principle Roles & Responsibility

  • Participate in the work related to new product introduction and organize the drafting of R&D related contracts.
  • Perform process transfer, process validation and cleaning validation of new products, draft process documents (process flow documents and master batch record, etc.) prior to product commercialization.
  • Participate in product-related design work, including but not limited to: new equipment design, tablet/capsule appearance design, printed packaging material design, inner packaging layout design, etc..
  • Cooperate with the preparation of relevant documents for product registration.
  • Review the validation documents related to the process and cleaning such as revalidation, continued process verification, etc. after commercialization of the product; review the process documents of commercialized products.
  • Cooperate with deviation investigation and change impact assessment in the production process.
  • Cooperate with the work related to the declaration of high-tech enterprises. Apply for R&D related government subsidies.
  • Other R&D related matters.

Qualification and Experience

  • Bachelor degree or above, pharmacy related majors.
  • At least five years working experience in oral solid dosage.
  • Familiar with the technical transfer, process validation and cleaning verification/validation.

If interested, please forward your resume to yuhuaw@hutch-med.com

职位名称 QC 分析员
部门 QC
工作地点 苏州

 

岗位描述

  • 负责QC实验室理化检测

主要职责/责任

  • 严格遵守实验室相关的各项标准操作规程及检测操作规程;
  • 执行原辅料、包装材料、中间产品及成品的放行测试,并起草相关的检验报告;
  • 成品的稳定性样品测试,并起草相关的稳定性报告;
  • 起草、修订物料(包括原辅料和包装材料)、中间产品和成品的化学分析检验操作规程及质量标准;
  • 起草、修订理化检测方法转移、方法验证的验证方案;
  • 按照验证方案执行化学分析方法转移、方法验证,及验证报告的撰写及覆核;
  • 起草、修订质量体系内本岗位相关设备、仪器、试剂、试液、标准品(或对照品)、滴定液标准操作规程;
  • 起草、修订实验室化学分析仪器确认方案;配合实施化学分析所用检验仪器的确认/验证、维护、校验;
  • 负责参与公用系统、关键生产设备和产品工艺验证、清洁验证等验证过程中涉及到的化学分析测试;
  • 报告本岗位引起不合格检验结果(OOS),按照上司的指导执行实验室调查;
  • 与政府药品检验机构进行沟通时配合提供具体信息;
  • 负责本岗位的安全、健康和环保(EHS)工作;
  • 完成领导分配的其他任务。

职位所需的能力与经验

  • 药学相关专业专科以上学历;
  • 2年相关工作经验;
  • 具备良好的理化测试技能和知识储备;
  • 熟悉理化实验室流程及法规要求;
  • 具备化学分析方法学经验者优先。

 
有兴趣者请联络∶ yuhuaw@hutch-med.com