External Supply Quality Assurance - API招聘_上海帝博企业管理咨询有限公司最新招聘信息-猎才医药网

职位描述

External Supply Quality Assurance - API（Contractor）全球最大动物保健公司因业务要求新增职位，负责供应商审核。要求候选人熟悉API工艺，英文可以流利沟通。出差比例10%，可选择在上海或苏州工作。由于公司目前效益很好，人头紧张，该职位为一年期contract合同，会与中智签合同。但是薪资福利和正式员工没有区别！感兴趣请把简历发到karen.kong@db-talent.cn的邮箱，或者可加VX：13917391573咨询Location: Shanghai or Suzhou, ChinaSCOPE OF THE POSITION:Support on Quality Oversight at External Manufacturing site (Scheduled visits) and maintain oversight for external manufacturer’s quality systems as they relate to Company Drug Products, APIs and other Animal Health related products, and ensure compliance with GMP / regulatory expectations.The Contingent Worker - External Supply Quality Assurance is responsible for:1.Supplier/Contractor Management: Ensure suppliers/contractors have applicable quality systems and comply with GMP/regulatory requirements and Company expectations for the product. Oversee GMP activities at suppliers/contractors, such as Change Control, Deviation Management, Lot Approval, Complaint Handling, Annual Product Reviews (APR), Stability Study, Validation Approval, Audit Support, Quality System Support and Metrics Review, etc.2.New Product Introduction (NPI): Support the selection, audit and evaluation of potential contractors in the process of NPI. Assess the quality and compliance status at contractors prior to sourcing decision. Carry out due diligence Quality audits as directed and make recommendations on suitability of contractors and new business opportunities. 3.Product Transfers: Act as QA support to Product transfer teams and advise such teams on Company expectation regarding process validation and Analytical Method Transfer Exercise (AMTE) performed at contractor. Supply QA approvals as required of the Transfer Plan and other activities, eg. Validation.4.Regulatory: Support or conduct Regulatory compliance assessment at contractor. Support the process of documentation retrieval and collation to support Manufacturing Authorization renewals. Assess risk for Annual Reportable changes and CBE’s and communicate/approve risk assessments when required. Act as QA focal point for regulatory communications and changes. 5.Contract Process: Support the Supply Agreement contract process by developing, negotiating the Quality Agreement and co-ordinate the quality document agreement and approval route ensuring all key quality requirements are met. Maintain established Quality Agreements with contractors.6.Other Contractor Assessments/Regulatory Inspections and Interactions: Facilitate and participate in assessment programs of contractors. Act as the Company representative in the event of an external regulatory inspection involving Company product at the contractor. Support contractor to develop and implement audit action plans, and track contractor CAPA plans to completion. 7.Development and Implementation of ESQA Guidelines & Policies: Contribute to the maintenance of the ESQA Quality System. Participate in developing ESQA Guidelines to ensure consistency of contractor standards across Company. Ensure a consistent approach to the interpretation and implementation of GMP standards and Company expectations.TECHNICAL SKILL REQUIREMENTS:1.Level of Education: M.Sc., B. Pharm, M. Pharm or equivalent degree2.Experience: Minimum 3-5 years of relevant pharmaceutical industry experience in QA and/or Manufacturing 3.Languages: Fluency in English, Any other language is an asset4.Computer skills: Advanced user-level of MS Office applications5.Profile: Ideal candidates should possess the following skills or have experience in the following:6.Experience that may include multifunctional, multi-site or other functional experience7.Working with multicultural, cross-functional work teams8.Experience in Quality Compliance functions9.Working knowledge of Quality Systems and Risk Management10.Knowledge of US FDA / EU GMP requirements impacting manufacturing operations11.Ability to work independently and in teams 职能类别：供应商管理药品生产/质量管理

公司信息

我们拥有专业的招聘顾问和专员，具有有多年的猎头从业经验，丰富的经历和广泛的当地人脉，借助公司信息系统能为客户提供高效，专业，准确的人才搜索服务。 DB Talent 致力成为人力资源服务领域的领航者，这意味着，充分利用人力资源、在不消耗或者极少消耗不可再生资源情况下创造更多社会财富。 DB Talent 猎头始终秉承“快捷、精准、规范、实效”的服务理念，坚持“专注，专业、真诚”原则，打造化工、汽车、机械制造、能源、房地产、金融行业以及人力资源职能领域专业的猎头机构。独特优势 1. 帮助高端人才主动出击，根据需求提供海量职位信息，成为高端人才的私人职业顾问。 2. 帮助价值被低估的优秀人才实现其应有市场价值；为客户公司寻找经济实惠型人才。 3. 通过深入的市场分析，候选人的沟通，可以为客户公司提供详细的竞争对手公司的组织架构，薪水等人力资源情况。精准快捷的搜寻能力：得益于深入的行业研究，DB Talent顾问及搜寻员知道候选人之所在，DB Talent顾问团队的领先的营销经验和能力，能让DB Talent猎头找到足够数量的优秀的候选人；这给DB Talent顾问评估候选人与您公司岗位的匹配性提供了可能，并保证在DB Talent确认您公司的岗位需求后七天之内有精英推荐。恪守职业道德：依托“有限客户原则”以及“不愿、不能、不敢”三级保密体系，DB Talent严格为客户保守商业机密、恪守商业道德。DB Talent猎头在您公司（用人机构、机构客户) 与候选人（个人客户）之间严守第三方公正的角色，确保双方的利益均得到正确对待。DB Talent猎头绝不包装简历、虚假推荐，以及恶意抬高或压低候选人薪资水平等。 DB Talent猎头承诺，合同期内，或者在与您签订合同后一年内，不主动从您公司中猎取人才。 DB Talent猎头向您提供三个月的保证期。由于候选人个人原因（指人才主动提出离职或不能满足岗位要求被贵公司辞退）离职的，在收到您的书面通知后，DB Talent猎头将免费推荐另一名合格人才到职。 DB Talent猎头承诺在与您公司和候选人交流时获得的信息仅用于猎聘使用，未经您及候选人允许，任何相关信息不得透露给第三方。 DB Talent猎头服务职场精英人士，决不会向候选人收取任何费用，任何以我公司名义进行的现场招聘活动、向人选收取费用的行为均为欺骗行为，提醒人选不要上当。 Our website:www.goodforjob.com Kindly Reminder: You could also send your resume with your photo, current detailed package and your expectation to admin@db-talent.cn 目前我们公司新开了微信平台(公共账号：dbtalent)，会专门提供高端点对点的个人猎头服务及行业资讯分享欢迎各界精英人士加入内部分享群。请回复您的姓名，所在的公司和本人的职务。由于申请入群人数较多，且对入群条件有要求，请耐心等候。

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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