General Mission职责概述

·
Operate QC analysis in compliance with analytical methods,
Assuring quality, Good Documentation Practices, cGMP, safety health and
environmental standards are met.

按照分析方法操作理化实验，确保符合质量、文件记录和GMP以及环境/安全/健康的要求。

·
Constitutes standard operating procedures, analytical
methods and perform the equipment qualification.

制定标准操作规程和分析检验方法，并执行设备的确认。

Activities具体职责

·
Analysis of raw materials,
semi-finished, finished products, validation sample and project sample according
to the analytical methods and pharmacopoeia requirements.

按照分析方法及药典的要求进行原辅料，半成品，成品，验证样品和项目样品的检验。

·
Executing analytical testing in a timely manner,
ensuring adherence to the committed scheduled plans.

及时执行分析测试，确保遵守承诺的计划。

·
Ensuring that he/she is trained and
qualified to the assigned analytical testing that requires to be qualified.

确保他/她接受过培训并具备指定分析测试所需的资格。

·
Performing the QC data review of
executed tests by other analysts in a timely manner, ensuring adherence to the
committed schedules plans.

及时对其他分析员执行的测试进行质量控制数据审查，确保遵守承诺的时间表计划。

·
Informing his/her manager of any
quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation
and impact assessment are performed appropriately.

及时向其经理通报任何质量或
HSE 事件（偏差、 OOx等），以确保适当进行调查和影响评估。

·
Participating actively to any
investigation, where he/she is involved, to ensure investigations and impact
assessment are performed appropriately.

积极参与其所涉及的任何调查，以确保调查和影响评估得到适当进行。

·
Executing assigned CAPAs related to remediation plans,
continuous improvements.

执行与补救计划相关的指定
CAPA并持续改进。

·
Ensuring that his/her lab/facilities, lab instruments,
are kept in a quality and safety status to ensure that they can be used
appropriately.

确保他/她的实验室/设施、实验室仪器保持质量和安全状态，以确保它们能够得到适当使用。

·
Implements the maintenance/validation/verification
of laboratory equipment in compliance with the established schedules and
maintain accurate records and documentation.

按计划对QC 实验室仪器进行维护、校准并准确记录和存档。

·
Maintain the reference standards
as well as the relevant documentation and record. Maintain the reagents and their records.

负责对照品的管理及记录。负责试剂的管理及记录。

·
Support the QC Supervisor with
writing draft procedures, draft qualification protocols of the analytical
instruments and the analytical methods. Perform the qualification work.

协助QC主管编写标准操作规程、仪器确认草案及分析方法验证方案。进行确认工作。

·
Implement stability study
according SOP and finish stability
report on time

负责管理执行稳定性考核工作，并及时完成稳定性考核报告。

·
To be the backup of the other
analysts in case of absent.

其它分析员缺席时作为替补。

·
Be responsible for HSE in his/her
position and job.

对本岗位的职业健康安全环境工作负责。

·
Other works assigned by the
leader.

上级安排的其他工作。

About you 任职资格:

List here ideally the must-haves
criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

·
Experience: More than two years working experience
in QC. Be familiar with chemical analysis
and have experience in analytical method and instrumental validation,including knowledge of Good Manufacturing Practices (GMP) and regulatory
requirements.

工作经验: 两年以上QC工作经验，熟悉QC 理化分析, 有分析方法和仪器验证工作经验，包括良好生产规范 (GMP) 和监管要求的知识。

·
Soft skill: Familiar to cGMP and regulation, Familiar
to office software, Good communication and transversally cooperation, team
leading

通用技能：熟悉现行GMP和法规，熟练应用办公电脑软件，良好的沟通协调能力，团队领导力。

·
Technical skill:

专业技能:

·
Familiar to CHP, Chinese & EU & United
state GMP, ICH regulation。

熟悉中国药典，中欧美GMP，ICH等法规。

· Ability to
analyze complex data and laboratory results to make informed decisions and
identify areas for improvement.

能够分析复杂的数据和实验室结果以做出明智的决策并找出需要改进的领域。

· Keen attention
to detail to ensure accuracy in testing, reporting, and compliance with
regulatory requirements.

高度重视细节，以确保测试和报告的准确性并符合监管要求。

· Proficiency in
identifying issues and implementing effective solutions to resolve quality
control problems.

能够熟练地发现问题并实施有效的解决方案来解决质量控制问题。

·
Education: bachelor’s degree above, Pharmacy or
related field

教育背景: 本科学位以上，药学或相关专业。

Languages: Good at English reading, writing，be
able to discuss the topics of quality and testing in English.

语言要求: 良好的英语读、写能力，可以用英语探讨质量和检验相关的话题