QC Group Leader(Drug Product)质量控制主管(成品） 苏州

月薪： 0.8-1万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-13 发布

职位描述

职位描述： Fundamental Responsibilities: drug product release and related work, including IPC testing, Cleaning Verification Testing, stability sample testing and supporting process validation.基本职责：成品放行和相关工作， 包括IPC测试,清洁验证测试, 稳定性样品测试和支持生产过程验证。1.Responsible for leading the drug product group to complete all drug product release and related testing within both procedural requirements and within QC Performance Metrics. Draft and review COA for release.负责按生产程序要求和公司业绩指标，领导成品组完成所有成品放行及相关测试。起草及审核COA。2.Responsible for performing method development, method verification or method validation, and technical transfer for supporting drug product release and related testing, including preparing and reviewing protocols and reports.负责执行用于支持成品放行及相关测试的方法开发，方法确认或方法验证，及技术转移，包括起草和审核方案和报告。3.Responsible for adjusting the workload of those in the group to meet the production department needs.负责调整成品组工作量以满足生产部门的需要。4.Conduct all work in strict compliance with US-FDA and CFDA regulations as required. Align synchronously with the revisions of USP and ChP.按照规定，严格执行美国FDA和中国CFDA的要求，同步调整美国药典和中国药典的版本更新。5.Responsible for OOS, OOT, OOAC and IR investigation.负责OOS、OOT、OOAC和IR调查。6.Work with Tech Documentation Group on SOPs, TMs, QSs, etc..和技术文件组一起完成SOP、TM、QS等。7.Train team numbers or others for conducting drug product release, related testing and related work.培训组内成员或其他人员执行成品放行、相关测试及相关工作。岗位要求：1. Bachelor or above degree. 本科或以上学历2. above 5 years' related experience in pharmaceutical chemical lab.五年以上制药实验室经验3. Fluent English 良好的英语沟通能力4.Analytical instrumentation and analytical methods in drug product release and related work.QC的成品放行和相关工作的分析仪器和分析方法。5. Compliance with GMP/cGMP for the US and China pharmaceutical industry.美国和中国制药行业的GMP/cGMP。6. Good communicating skills and management skills. 良好的沟通和管理技能。 职能类别： 药品生产/质量管理 化学分析测试员

联系方式

苏州工业园区群星一路58号

公司信息

Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products. Its headquarter is based at New Jersey, US. 爱美津制药是一家集研发和制造于一体的跨国公司，旨在向美国提供高质量的仿制药品。总部位于美国新泽西州。 With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service. 凭借在美国和海外的制药资产和技术专家队伍，爱美津致力于提供高品质产品、有竞争力的价格和无以匹敌的客户服务。 At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd. 2007年底，爱美津完成了在中国苏州工业园区的口服固体制剂生产厂的收购，并成立了苏州爱美津制药有限公司。 The milestones of Suzhou Amerigen are as follows: 苏州爱美津制药的里程碑如下： 2007 Suzhou Amerigen was established 苏州爱美津成立 2008 First US regulatory filing 首次获得美国法规文件受理 2009 First US FDA PAI & General Inspection 首次美国食品药品监督管理局上市批准和常规检查 2010 Received US FDA approval for bulk tablet manufacturing 获得美国食品药品监督管理局的批准生产大包装片剂 2012 Passed CFDA Re-Inspection (GMP 2010 version) 通过中国食品药品监督管理局再次检查-新版GMP (2010版) 2013 Passed US FDA Inspection –Recommended approvals on four ANDAs 通过美国食品药品监督管理局检查- 4个简化新药被推荐批准 2014 Launched US Product and re-introduced China Products 产品在美国市场上市, 中国市场产品恢复生产。 2015 Passed US FDA Inspection on Data Integrity 通过美国食品药品监督管理局针对数据完整性的专项检查

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