10 Jan, 2022

QC Chemical Engineer I

  • Thermo Fisher Scientific
  • Hangzhou, Zhejiang, China
Chemical Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

职位概述JOB SUMMARY:

 

执行QC化学分析实 验室相关活动,确保符合EHS,GMP,及公司政策和流程的需求。Execute QC chemical lab relevant activities, to ensure compliance with EHS and GMP requirements as well as company policies and procedures.

该职位在QC化学分析团队扮演重要的角色。作为领域专家参与化学化学实验室建立,实验室日常运行,样品测试,文件记录和审核,仪器日常管理,实验室调查,以及持续改进工作。This position will play an important role in QC chemical team. Work as a subject matter expert in chemical lab setup, lab routine operation, sample testing, document record and review, instrument routine management, investigation and keep continuous improvement.

职责RESPONSIBILITIES:

  • 确保安全第一的安全理念得以充分的贯彻实施,并使其尽可能在整个组织中不断提升。Ensure the safety message that the first goal of all employees is safety is implemented and lived throughout their organization and bolster this throughout the facility as possible.
  • 根据已开发的理化,生化和药典测试方法执行药品原材料,中控产品,最终产品和稳定性样品所需要的化学测试。Conducts chemical testing of pharmaceutical raw materials, in process control, finished products, and stability samples by developed physical-chemical method, bio-chemical method and compendial test methods.
  • 准确清晰的记录和汇总分析结果,根据实验室流程要求记录和报告结果,可能需要与客户进行沟通。Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports result of analysis in accordance with prescribed lab procedures and systems. May interact with clients.
  • 发起问题报告, 包括偏差,仪器运行失败,纠正预防措施等,参与实验室偏差,OOS, 投诉等的根本原因分析。Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) and performs root cause investigation and analysis for lab investigation, OOS and complaints.
  • 参与QC化学分析组的方法验证,方法确认和方法转移活动。QC chemical team method validation, method qualification and method transfer activities.
  • 参与稳定性研究活动,准确可靠执行数据检查和转移。Participate in stability study activities and ensure reliable data check and transfer.
  • 更新QC化学分析组相关的SOP, WI, 分析方法,表格,研究方案和报告等,以符合实验室日常运行和持续改进的需求。Update QC chemical team SOP’s, WI’s, test methods, forms, study protocols, reports etc. to align with current laboratory practices and continuous improvement.
  • 根据需要,对于新的或已有的QC化学分析组的分析方法和方案,对新的或当前的QC化学分析组技师进行培训。Train new and existing QC chemical technicians on new and existing QC chemical test methods and protocol as required.
  • 配合QC技术支持组开展化学分析组的仪器确认活动,确保所负责仪器处于被确认的状态。Support chemical lab instrument qualification activities with QC Technical Service team, ensuring responsible instruments at qualified status.
  • 维持实验室相关试剂耗材的库存和供应,确保QC化学分析组试剂耗材备货充足。Maintain laboratory testing inventory and supplies, ensuring QC chemical lab is well-stocked and resourced
  • 执行主管分配的其他活动。Perform other activities as directed by supervisor.

要求REQUIREMENT

 

教育程度Education:

  • 生命科学,化学,生物工程学,制药学或其他相关专业学士学位或以上Bachelor’s Degree or above in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area.

 

经验Experience:

  • 至少1年制药行业质量工作经验At least 1 years of quality experience in pharmaceutical industry.
  • 具有实验室测试,方法验证和实验室运行经验Experience in lab testing, method validation and lab operation.

 

能力要求Competencies:

  • 具备生物化学和生化分析问题解决和数据管理工具使用的知识Knowledge of biologic chemical and bio-chemical analysis problem solving and data management tools.
  • 具备GMP实验室运行的实践知识Practical knowledge in GMPs and comprehensive capabilities of lab operation.
  • 具备化学分析相关仪器的知识,比如HPLC, UPLC, CE, 读板机, Q-PCR, GC, UV, IR 等Knowledge of chemical analysis instrument techniques is required (HPLC, UPLC, CE, Plate Reader, Q-PCR, GC, UV, IR etc.)
  • 优秀的组织能力,使所有范围井井有条Good organization ability to keep all the scope organized.
  • 基本的实验室调查技能和解决问题能力Basic lab investigation and troubleshooting skills.
  • 较强的人际交往和沟通技巧Strong interpersonal and communication skills.
  • 持续改进的意识Continuous improvement mindset.

语言Languages:

  • 中文和英文Chinese and English
  • 熟练的英文听说和写作能力,可使用英语作为工作语言Proficient in using English as working language at listening, speaking and writing.

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