质量控制理化分析员
质量控制理化分析员
8.4-11.2万
苏州工业园区 | 无需经验
发布时间:2021-09-04 13:20:11 | 截止时间:2022-09-30
基本信息:
  • 化学分析测试员
  • 应届毕业生
  • 全职
  • 4
  • 质量部门
  • 质量理化经理
职位描述及要求:
  • Job Functions 工作职责
    Including but not limited to 包括但不限于:
    Laboratory equipment 实验室仪器
    Responsible for managing and performing equipment qualifications and calibration
    负责管理和执行设备的确认、校准活动
    Draft instrument use and maintenance procedures, perform routine instrument maintenance and PM as required to maintain testing equipment at a validation state to ensure accuracy of test results
    制定仪器使用和维护策略,按要求执行仪器的日常维护和 PM,确保仪器处于验证状态,以保证检测结果的准确。

    Testing 检测
    Execute the physiochemical tests contain samples from release, stability and IPT. Finish the related record writing and reviewing.
    按要求执行包括放行、稳定性和 IPT 等样品的理化项目的检测,及时完成相关记录的书写和复核。
    Ensure the timely disposal of tested samples
    确保及时处理测试样品
    Identify the event in the test process, investigate and find the root cause, make the CAPA plan in time.
    敏锐识别检测过程中的异常情况,合规及时的完成根本原因的调查,并制定解决策略。
    Create and review methods and procedures for completeness and accuracy
    创建并审查方法和程序的完整性和准确性
    Comply with safety guidelines
    遵守安全准则
    Learn and comply with GLP, and cGMPs, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.
    学习并遵守 GLP 和 cGMP,包括但不限于培训记录,实验室笔记本,书面程序,设备监控系统和实验室日志的维护。

    Method transfer and validation
    Draft and review method transfer, method validation protocol and report. Then execute them effectively. Judge the effectiveness of the test transfer and validation accurately.
    独立起草审核方法转移、方法验证方案和报告,有效执行方法转移和验证活动,并能够准确判断方法转移和验证是否达到预期目的。
    Draft the related SOPs and data management strategy according to the result of method transfer and validation.
    根据方法转移和验证的结果制定相关的操作规程和数据管控策略。

    Team work 团队协作
    Guide and train some new employees about the compliance and technical.
    对新员工和组内成员给予合规和技术的培训和指导
    Work with team members to finish the test and other issues in lab.
    与团队其它成员共同完成检测、实验室运营等相关工作。
    Finish the routine lab management issues, contain consumable purchase application, reagent management.
    有效完成实验室日常管理工作,如耗材的申购,试剂的管理。
    Capability of identifying the risks.
    具有识别风险的能力。
    Authoring for new and revise documents, participation on investigation teams, input to quality systems (change control, CAPA, and deviations)
    编写新的和修订的文件,参加调查团队,输入质量体系(变更控制,CAPA 和偏差)
岗位条件:
  • 本科
  • 英语 良好
  • 医药卫生类>制药工程
  • 不限
您也可以使用手机扫描二维码分享这个职位给朋友们
  • 私营企业
  • 制药/生物工程
  • 苏州大道西119号苏悦商贸广场南楼20层2005
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