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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

職位名稱 QC 分析員
部門 QC
工作地黠 蘇州

 

崗位描述

  • 負責QC實驗室理化檢測

主要職責/責任

  • 嚴格遵守實驗室相關的各項標準操作規程及檢測操作規程;
  • 執行原輔料、包裝材料、中間產品及成品的放行測試,並起草相關的檢驗報告;
  • 成品的穩定性樣品測試,並起草相關的穩定性報告;
  • 起草、修訂物料(包括原輔料和包裝材料)、中間產品和成品的化學分析檢驗操作規程及質量標準;
  • 起草、修訂理化檢測方法轉移、方法驗證的驗證方案;
  • 按照驗證方案執行化學分析方法轉移、方法驗證,及驗證報告的撰寫及覆核;
  • 起草、修訂質量體系內本崗位相關設備、儀器、試劑、試液、標準品(或對照品)、滴定液標準操作規程;
  • 起草、修訂實驗室化學分析儀器確認方案;配合實施化學分析所用檢驗儀器的確認/驗證、維護、校驗;
  • 負責參與公用系統、關鍵生產設備和產品工藝驗證、清潔驗證等驗證過程中涉及到的化學分析測試;
  • 報告本崗位引起不合格檢驗結果(OOS),按照上司的指導執行實驗室調查;
  • 與政府藥品檢驗機構進行溝通時配合提供具體信息;
  • 負責本崗位的安全、健康和環保(EHS)工作;
  • 完成領導分配的其他任務。

職位所需的能力與經驗

  • 藥學相關專業專科以上學歷;
  • 2年相關工作經驗;
  • 具備良好的理化測試技能和知識儲備;
  • 熟悉理化實驗室流程及法規要求;
  • 具備化學分析方法學經驗者優先。

 

有興趣者請聯絡︰ yuhuaw@hutch-med.com