Technical Documentation Supervisor 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
  • 11-09 发布

职位描述

职位描述： 1. Be responsible for creating, revising, reviewing and/or improving lab related technical documentation at Amerigen, including but not limited to: SOPs, Test Methods, Protocols and Reports, Quality Standards and COAs. Documentation sources include AS, QC, QA and FR&D. Majority of Documents are in English and/or bilingual.Communicates/ negotiates efficiently with other department for addressing varying opinions quickly to ensure smooth and timely development of documents. The final deliverables technical documents must comply with applicable procedures and Quality Department requirements.负责建立、修改、审核和/或改进在爱美津的实验室相关技术文件，包括但不限于：标准操作规程、测试方法、方案和报告，质量标准和分析证明书。文件来源于分析服务、质量控制、质量保证和处方研发部门。大部分文件应为英文和/或中英双语的。与其他部门有效沟通/协商，快速解决不同意见以确保文件生成的顺利性和及时性。最终交付的技术文件必须遵循其适用的规程和质量部门的要求。2.Review and track the revision of Pharmacopeia for commercial product and related material and other general changes. And revise relevant documents as needed.审核并追踪商业化产品相关的物料和其他常规章节的药典更新，并根据需要修订文件。3.Train/guide associate person on Technical Document Writing.对相关人员进行技术文件写作的培训/ 指导。4.Other tasks assigned by Superior.上级安排的其他任务.岗位要求：1. Bachelor or above degree in Pharmacy/ Chemistry or equivalent.本科及以上学历，制药、化学或相关专业。2.GMP/ GLP/ USP/ ChP/ QMS related experience in Pharmaceutical industry制药行业中GMP/实验室/美国药典/中国药典/质量体系相关经验。3.at least 6 years experience, in which 3 years lab experience至少6年工作经验，其中3年实验室经验。4. Fluent English, both in oral and writing.熟练的英语能力。5.Excellent Negotiation/Communication skills; Strong Problem-solving skills; Strong Organization skill, Self-Motivated. Ability to work with minimal direction and. /or direct supervisory oversight.卓越的协商/沟通技巧，强大的问题解决能力，强大的组织能力和自我激励，能在较少的指导下或直接监督下进行工作。 职能类别： 质量管理/测试主管(QA/QC主管) 药品生产/质量管理

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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