Offers “Sanofi”

Expires soon Sanofi

IA-QC Technician-Hangzhou

  • Internship
  • Hangzhou, CHINA

Job description



Conducts testing in compliance with all regulatory and technical requirements, and contributes to maintain the QC activities (documentation, methods, competencies etc.) at the required operating level.

岗位要求:

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。

KEY ACCOUNTABILITIES关键职责:

·  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。

·  Assures that analysis  is  carried out on time and are in compliance with the Specifications. Participate in the OOS investigations.

确保样品及时检验并符合质量标准的要求。参与检验异常情况的调查。

·  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。

·  Other works assigned by the leader.

上级安排的其他工作。

Education / Experience教育及经验要求:

Must to have : 最低要求

Education教育: Bachelor degree/大学本科

Professional /Major专业:Pharmacy  related major/药学相关专业

Experience 经验: At least 1 year chemical analysis experience in QC or 2 year experience in Pharmaceutical.

至少一年QC 理化分析工作经验或2年以上药厂工作经验。

Better to have : 优先考虑项

Education教育: Postgraduate研究生

Professional /Major专业:Pharmacy analyst药物分析专业

Experience 经验: More than two years working experience in QC. Be familiar with  chemical analysis and have experience in analytical method and instrumental validation.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。

Technical skills & Competencies / Language 技能及其他能力要求

Must to have . 最低要求

Technical 技能: Can operate the analytical instrument in QC such as HPLC, GC, UV, IR, Dissolution tester. 能操作实验室基本分析仪器,如高效液相,气相,紫外,红外,溶出仪等。

Language语言: Basic English reading and writing. 英语基本读写能力

IT Skill电脑技能: Basic office tools基本办公软件操作

Other Ability其他能力: Co-operate with the team团队合作

Better to have : 优先考虑项

Technical 技能: Can operate and maintains the  analytical instrumental such as HPLC, GC, UV, IR, Dissolution tester. 能操作及维护各种分析仪器,如高效液相,气相,紫外,红外,溶出仪等。

Language语言: Communicate fluently in English.能用英语交流。

IT Skill电脑技能:  Senior in office software . 熟练使用办公软件。

Other Ability其他能力NA

Future challenges 未来的挑战:Strive for the annual target and become an expert in the responsible field/达成年度目标并成为负责领域的专家

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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