Senior GMP Specialist 药品生产质量管理规范高级专员招聘_美药典标准研发技术服务（上海）有限公司（美国药典）最新招聘信息-猎才医药网

职位描述

职位描述： Senior GMP SpecialistJob DescriptionThis is a hands-on, non-supervisory position where the incumbent understands the standards and principles of auditing manufacturing facilities for current good manufacturing practice (cGMP) compliance. The incumbent will analyze all elements of a quality system and judging its degree of compliance with the criteria of quality management, evaluation and control systems. The individual leads companies in compiling dossiers for World Health Organization (WHO) prequalification, US FDA’s ANDA, EDQM’s CTD, EMA’s CTD and other dossiers. The incumbent establishes manufacturing, QA, QC process, and documentation requirements for WHO prequalification, USFDA EDQM, EMA and other regulatory programs. He/she partners with the director in the evaluation of cGMP, QA, and manufacturing batch records received from manufacturers. Contributes to qualify pharmaceutical manufacturers for essential drugs supply chain management as well as for generic industry for affordable drugs worldwide.Roles and Responsibilities:?Designs and develops work plans and new proposals for submittal to USAID and/or other donors to obtain new funding mechanisms.?Manages country-specific and/or regional projects for USAID cooperative agreement as assigned by US Missions in different countries.?Develop training materials and conduct workshops on GMP compliance and product dossier evaluation.?Identifies and supervises consultants in the different countries who are working for GMP group, if needed.?Prepares work plans and quarterly progress reports; contributes to annual USAID portfolio review process.?Explores new opportunities for work in the international arena and for collaboration with other international organizations; develops and drafts proposals for international projects and activities.?Reviews pre-audit information submitted by pharmaceutical ingredient manufacturers and makes recommendations on the readiness for a formal audit.?Conducts site audits of drug substance and FPP manufacturing sites as the lead auditor for a team of two.?Creates final reports summarizing the results of the site audits and makes recommendations to the PQM GMP specialist regarding a site’s compliance with GMP.?Reviews submitted reports and makes final recommendations to the GMP specialist regarding a site’s compliance with GMP, when contract auditors have been used.?Prepares final disposition reports combining the audit report and document review for submissions to USAID.?Develops and updates USP SOP's and policies related to the conducting of GMP audits for compliance.?Provides input designed to update USP’s “Guidelines for Participants” and other documentation intended to assist current and potential participants in the program offerings.?Participates in developing and conducting training programs for potential auditors leading to certification.?Train GMP specialist in Dossier review and GMP audit process.?Performs other related duties as assigned.Basic Qualifications?Bachelor’s degree and seven years of experience in the pharmaceutical industry and/or government drug regulatory authority required. US FDA, EDQM, EMA, TGA and other experience strongly preferred.?Minimum of five years’ experience in at least two of the following: Pharmaceutical GMP Inspections, pharmaceutical supply chain management, pharmacology, medicines evaluation.?Three years of training and management experience in international programs, developing countries preferred.?Excellent communication skills MS Word, Excel and PowerPoint skills required?Ability to travel at least 20-25% of the time both domestic and internationally.Preferred Qualifications?Knowledge in CGMP drug development to commercialization.?Knowledge of developing countries for both public health sector and generic pharmaceutical market including testing and manufacturing.?Excellent verbal, written and presentation skills; grant writing experience helpful.?Ability to network with professionals from WHO, UNICEF, UNIDO, USFDA, EDQM, EMA, GDF, Global Fund and other donor foundations as well as local in-country representatives and government officials. Ability to work with virtual teams in remote locations.?Ability to work with nationals from varied backgrounds and cultures. Language skills a plus (English, Spanish, French, Arabic or Mandarin). 职能类别：生物工程/生物制药药品生产/质量管理

公司信息

关于美国药典委员会美国药典委员会（USP）是一个独立的非营利组织，也是一家具有全球影响力的标准制定机构，在全球范围内开展药品和食品（包括膳食补充剂）的标准制定、认证及培训等相关业务。权威性： USP 成立至今已有近 200 年历史； USP 颁布的药品标准是美国国家法定标准，由美国食品药品管理局（FDA）强制实施， USP 食品成分和膳食补充剂标准是行业普遍使用的推荐标准； USP 专家委员会汇集了包括中国、美国在内的来自监管机构、业界和学术界知名专家；膳食补充剂第三方认证广受美国大型零售商以及药师、营养师的信赖和推荐。全球性： USP 标准和标准品在全球 140 多个国家被广泛使用；在美国、中国、印度、巴西、瑞士、加纳、埃塞俄比亚等国家设有分支机构。关于美国药典委员会中华区总部美国药典委员会中华区总部是美国药典委员会（USP）在中华区设立的全资分支机构。美药典委员会中华区总部于 2006 年在上海张江成立的，随着中国业务的蓬勃发展，2012 年美药典决定增加在华投资，选址外高桥成立“美药典标准研发技术服务（上海）有限公司”。并于 2014 年 1 月起开始正式运营。美药典目前在中国的主要业务分为两部分：承担美国药典总部派发的药典标准和标准品研发任务。涉及的范围包括药品、原料药、辅料、生物制品、膳食补充剂和食品成分等。为中华区使用美国药典的用户提供客户服务、技术培训、认证支持，帮助他们出口产品到美国和其他认可美国药典标准的国家。美药典凭借其在标准研发领域的权威性和技术领先性，先后被列为“技术先进型服务企业”、 “保税监管试点企业”及外商投资“研究开发中心”。美药典拥有 ISO9001 质量体系认证和 ISO17025 实验室认可证书。 2014 年 9 月 18 日国务院总理***在自贸区成立一周年之际视察了美药典，对美药典以标准合作推进中药国际化、促进中国食品医药保健品企业出口所做的努力给予了肯定。 USP中国为您提供实现理想的工作机会，也为您提供与世界各地的科学家、企业合作伙伴、医疗健康机构和政府领袖交流的平台。我们致力于招聘并培养有能力、诚信、充满活力并有热情与我们共同提高全球健康而努力的员工。我们的组织文化, 关注员工授权,职业发展,开放式沟通,和组织的透明度。我们热忱期待您的加入！更多关于USP 的信息，欢迎访问我司网站www.usp.org

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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