• 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述: Job SummaryThe core responsibility of the position is to inspect, analyse and process all raw materials according to CHP, USP, EP and other related requirements.Main Responsibilities? Inspects raw materials in accordance with established procedures and in compliance with CHP, USP, EP, and related requirements to release the raw materials within 5 working days averagely.? Submits accurate, precise and complete reports in a timely fashion. Exhibits a working knowledge of Colorcon Oracle database applications to maintain accuracy of records.? Maintains an awareness of cGMP and cGLP and maintains compliance with those regulations; documents all activities associated with cGMP compliance (i.e. instrument calibration, OOS investigations etc.)? Prepares testing method for raw materials according to global working specifications.? Release trading products and inputs data for generation of Certificate of Analysis from Oracle within 2 working days averagely.? Performs microbial testing for auditing test of finished goods and routine test of raw material, and support the environment monitoring.? Effectively communicates with supply chain personnel (functions including receiving and warehouse, planning and purchasing) in related with the raw material related issues.? Performs other duties assigned by direct manager, including but no limited to participate in special projects, perform duties in compliance with Colorcon laboratory practices, training other colleagues in quality department.Key Performance ObjectivesIn the first 3 monthsLearn about company business/products/key processes. Learn how to use role based working system (Oracle and OneSource etc.) to perform duties. Pass orientation test defined for the role to demonstrate understanding of the basic working knowledge.2In the first 6 months Compete the tests independently and timely based on operations schedule and deadlines. Convert the methods of CHP to the applicable Colorcon QC raw material test sheets.In the first 1 year Perform OOS investigation and complete reports accordingly within 2 weeks. Can operate GC、HPLC、Microbiology testing and AAS independently. Achieve the key objectives set for the role.Requirements:? College or above in pharmacy or chemical or food related.? Minimum 1 years’ experience in Chemical and instrumental analysis in a CGMPpharmaceutical or chemical or food work environment.? Ability to prioritize the work on a reasonable and effective basis.? Familiar with pharmacopoeia compendia, such as CHP, USP and EP.? Ability to use computer effectively including Outlook, MS Office (Word, Excel, andPowerPoint) & good English skills in reading and written.? Proactive and has high sense of responsibility.? Be able to work shift. 职能类别: 质量检验员/测试员 化学分析测试员

联系方式

上海闵行区

公司信息

上海东浩人力资源有限公司前身为上海外服子公司--上海浦东外国企业服务有限公司,经过15年的发展,已成为国内人力资源服务行业领先企业。2010年,在人力资源服务产业国际化的环境中,世博集团作出了“一体两翼”的战略布局,将原上海外服招聘中心的力量注入上海东浩人力资源有限公司,整合共享上海外服已有技术平台和人才数据库,旨在打造覆盖全国的以招聘服务能力为核心的新型人力资源服务平台。迄今为止,已向8000余家外商投资企业提供了数十万名专业人才。

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