GMP Auditing Manager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： Summary of the Position:This is a hands-on, technical position responsible for conducting documentation audits and on-site current Good Manufacturing Practice (cGMP) audits of USP Verification Program (VER) participants, reporting the audit findings to the Sr. Director, Verification Programs or designee, and following up with the VER participants to ensure that they implement acceptable corrective action for all audit findings. VER participants to be audited primarily will include pharmaceutical ingredient, excipient, and dietary ingredient manufacturers, as well as dietary supplement manufacturers. This person will also work closely with Strategic Customer Development team in China to develop new customers for the VER programs. As a QA team member, this person directly reports to Sr. Director, Operations, China for the moment, and eventually will report to QA head, China. This person also provides support to conduct auditing of testing records/reports of Verification samples tested at USP-China and USP-China supplier management, and other auditing and QA activities as appropriate and assigned.Roles and Responsibilities:GMP Auditing and Analytical Testing:?Reviews pre-audit information submitted by VER participants and makes recommendations on the participant’s readiness for a formal audit.?Conducts cGMP site audits of active pharmaceutical ingredient (API), excipient, and dietary ingredient and dietary supplement manufacturing sites, according to the appropriate cGMP guidelines and VER program requirements.?Acts as an interpreter for USP VER during audits and ensures that translations performed by Chinese participating companies (both written and verbal) are accurately recorded.?Creates audit reports in a timely manner summarizing the results of the site audits and makes recommendations regarding site compliance with cGMP requirements.?Where contract auditors have been used, reviews submitted reports and makes final recommendations regarding site compliance with cGMP.?Conducts site audits of contract testing laboratories, prepares audit reports in a timely manner and makes recommendations regarding laboratory compliance with VER requirements.?Reviews ingredient chemistry, manufacturing and control (CMC) or dietary supplement quality control manufacturing (QCM) documents submitted by VER participants.?Follows-up with VER participants for corrective action audit response and compliance with VER requirements, and provides a status report.?Prepares project plan or test protocol for samples under verification and obtains VER and/or USP’s Quality Assurance Group (QA) approval prior to its implementation.Departmental Activities:?Develops and updates VER SOPs, participant manuals, and other documents periodically in collaboration with QA and VER Staff.?Effectively assists chemists who conduct major analytical work by ensuring testing is carried out in accordance with the project plan.?Reviews and manages internal audit reports of VER participants and coordinates with VER to respond and initiate corrective action for audit findings.?Works closely with Strategic Custom Development team in China to develop new customers.?Works collaboratively with VER staff based at USP sites globally.?Coordinates with VER participants for surveillance testing and required documents as per VER requirements.?Completes requisition orders and expense reports for travel and materials related to VER activities.?Keeps track of time directly spent on VER project work and reports information on a monthly basis.?Participates in monthly international verification team conference calls.?Performs other duties as assigned.Secondary Responsibilities:?Conducts site audits of active pharmaceutical ingredient (API) and dosage form manufacturers for Global Health Impact Program (GHIP) or Promoting the Quality of Medicines (PQM) , when required.?Prepares audit reports summarizing the results of the site audits and makes recommendations to the Program Manager – GHIP or PQM regarding site compliance with cGMP requirements.?Follow-up with manufacturers to verify corrective action stated in the audit response report and prepare status report for Program Manager – GHIP or PQM.Minimum RequirementsEducation and Experience:?M.Sc. or Bachelor degree (or equivalent combination of education and experience) in the field of Chemistry, preferably synthetic organic chemistry, analytical chemistry, or other related fields.?Minimum of five 5 years of relevant experience working directly within cGMP facilities engaged in the manufacture and/or quality control/assurance of either bulk active pharmaceutical ingredients (APIs), excipients, and/or dietary ingredients and their finished dosage forms.Knowledge, Skills and Abilities:?Should have extensive knowledge of FDA regulations pertaining to cGMP requirements, ISO 9001 and ISO 17025. A certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is strongly preferred desirable.?Working knowledge with International Conference on Harmonization (ICH) quality guidelines, and multidisciplinary guideline on on and multic the Common Technical Document (CTD) format for APIs, is desirable.?Proficient with regulation and guideline interpretation, audit procedures, proper documentation, and QA and departmental policies and procedures.?Industry experience in the establishment of quality systems compliance is preferred. Knowledge of and experience with routine analytical methodologies is desirable.?Good organizational and planning skills; and excellent verbal and written communication skills (English and Chinese). Should be detail oriented; able to deal with multiple changing priorities; and able to work under with minimal supervision.?Effective and efficient project management experience and CMC submission experience is preferred, especially CMC section authorship desirable.?Must be willing to travel approximately 40% domestically and internationally. 职能类别：生物工程/生物制药供应商管理

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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