PCH APAC CEP Regional Lead招聘_惠氏制药有限公司最新招聘信息-猎才医药网

职位描述

职位描述： ROLE SUMMARYThe PCH Regional CEP Lead (APAC, LATAM or EMEA) will be responsible for ensuring compliance, usage of the CEP Processes and manage their respective Regional CEP Approval Committee for the regional teams. The role will report into the Sr. Manager, PCH NA Regional CEP Lead.ROLE RESPONSIBILITIES?PCH OversightoWill provide oversight into the PCH CEP activities for their regions and will share their findings with te NA PCH Regional CEP lead?Program Owners supportoProvide support to Program Owners in design phase and navigating the CEP process in a compliant manneroMonitor CEP compliance during the conduct and close-up phases?Training and Change ManagementoProvide thought leadership and periodic CEP updates in Region and Markets or equivalent In partnership with GCO LeadoConduct training of key stakeholders in CEP process (e.g. POs, CEP Champions, Vendors, etc.)oMonitor training compliance in CEP process (e.g. Program Owners, Vendors, etc.)?Local CEP Committee ManagementoDevelop the agenda and logistics of the CEP CommitteesoLead the CEP Committees during approval meetings and mediate between the Program Owner and the Committee’s recommendationsoInform corresponding Regional Committees of the multi-country programs that apply to the country?Best Practices and Improvement InitiativesoIdentify and communicate to PCH NA Regional CEP Lead best practices and improvement opportunities in the CEP processoIncorporate best practices and improvement initiatives pushed by the CEP CoE and GCO Regional CEP LeadoSupport Committee in the oversight of key metrics and quality measuresoReview best practices resulting from programs conducted in the region?Policies and Procedures follow upoCommunicate changes to CP 902 and CP 902a to internal and external stakeholdersoMonitor changes in country regulations relevant to CP 902 and CP 902a and communicate them to PCH NA Regional lead and into the GCO Regional CEP Lead?Audits, Inspections and Quality MonitoringoSupport countries to be prepared for audits and inspectionsoMonitor the implementation of CAPAs defined by MQO (SRQ in US)oKeep track of CEPs, providing status and trends to key internal stakeholdersoReview of exception reports and follow up with POs for flagged programs until it is solvedoShare CEP quality report results with Local CEP Committee and CMF or equivalent to build CEP awarenessoParticipate and be involved in post-audit meetings if findings cover CEPs?Vendor OversightoSupport the activities of vendor oversight as needed in partnership with Global Procurement and the CEP CoEoMonitor Ariba for vendors being on-boarded for potential CEP engagementsoIdentify vendors not complying with CEP processes and requirements and define applicable CAPAs?CEP Issue Resolution and TransitionoActively resolve outstanding CEP tasks and issues with the correspondent functional areas (e.g. Regulatory, Legal, Compliance, etc.) and the POoSupport PO transition with the PO Manager to transition CEP ownership, even after the program end dateQUALIFICATIONS?Bachelor's degree required?8+ years experience in the pharmaceutical industry with OTC experience preferred?Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis?Strong project management, organizational and excellent platform / communication skills?Experience in working through a matrix organization?Ability to work effectively and collaboratively with CEP Center of Excellence and other PCH Regional CEP LeadsPHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.?Understand the fundamentals of drug safety and risk management (e.g. Adverse Event reporting), CEP processes, policies and procedures and/or compliance background?Strong analytical skills; ability to analyze information, draw insights and recommend improvements; ability to synthesize problems and develop innovative solutions and strategies?Strong customer service skills?Ability to demonstrate strong facilitation and collaboration skills?Proficient in project management skills?Proven ability to drive execution of strategies?Proficient in common technical tools (e.g. Microsoft Office)?Strong written and oral communication skills?Strong English language skills?Ability to manage multiple tasks and work across a matrix organization 职能类别：生物工程/生物制药

公司信息

辉瑞苏州药厂（惠氏制药有限公司）是世界五百强公司之一，成立于1991年7月，并于1994年11月正式投产。经过历次增资扩建，累计总投资额超过1.3亿美元，目前厂区面积43亩，共有员工近800人。公司拥有按GMP标准建造的洁净厂房和世界先进水平的生产设备和技术。主要产品有钙补充剂、多种维生素、抗感冒咳嗽药、抗生素等多种处方药和非处方药，共计33种产品163个产品规格。除了满足国内市场的需求，部分产品已大量出口亚太地区以及拉丁美洲等12个国家和地区，成为集团亚太地区重要的供应基地之一。公司采用全球最先进的质量管理制度和保证体系，其质量管理水平和记录在辉瑞全球生产制造集团中首屈一指。自1998年至今，公司通过了每一次国内外GMP审查并获得认证，为产品质量提供了强有力保障。为了进一步提升企业的质量标准，公司在内部实施 "持续规范运作"。持续规范运作的实施进一步提高了公司的GMP质量管理体系和运作水准，使公司的质量管理体系在同行业内处于领先地位，并多次受邀与国家、地方药监部门进行质量体系管理成果分享活动。多年来公司一直延续着优异成绩，在内外部都取得了丰硕成果。截至到2015年，已经连续七年获得了总裁奖、连续六年获得***客户服务奖。2014年，公司更是战果辉煌，获得了辉瑞全球供应集团最高荣誉--总裁钻石奖，并成为辉瑞全球年度***工厂！公司曾获得过"江苏省质量信用等级A级企业"、"药品质量诚信建设示范企业"、"江苏省医药行业诚信企业"、"苏州市质量奖"、 "中国能效之星"等荣誉称号，并连续10多年获得苏州市、吴中区纳税大户称号，江苏省及苏州市各级领导多次来公司参观访问，他们都高度肯定了我们的成绩，以及对地方经济作出的杰出贡献。在总部和苏州市及吴中区政府的大力支持下，辉瑞苏州新厂项目于2014年10月正式签署投资协议并于2015年10月正式动工，已于今年8月全面封顶，新厂位于苏州市吴中经济技术开发区吴淞江科技产业园，一期占地约70亩，投资约9600万美元，主要生产钙尔奇、善存系列产品，同时，还将在新厂建立新平台，并设置辉瑞健康药物部亚太区研发中心，为保证市场发展后劲注入源源不断的新动力。届时，辉瑞苏州将成为辉瑞全球最大的钙尔奇、善存生产基地。建成后，一期片剂生产能力将达到38.5亿片/年，预留产能10亿片/年，预计2018年一季度投入商业化生产，项目还为未来发展留有二期、三期规划。新厂设计秉承了绿色环保、高效节能、可持续发展的理念，并将成为药品生产车间和综合楼LEED（美国绿色建筑协会能源和环境设计先锋奖）金级认证的行业先锋。辉瑞苏州始终不断地坚持发展和自我改善，激励和吸引所有员工一起以辉瑞愿景为目标，力争做到快速、灵活、创新、以业务为中心和网络驱动，工厂还重点关注客户服务、成本效益、员工参与、改善内部流程等。我们已制定"成为具有创新精神的辉瑞全球业务伙伴并为客户创造最大价值"的2020战略目标。伴随新厂项目的建成，新的蓝图已经绘制，我们将继续努力，一步一个脚印地迈向下一个辉煌！

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

上海相关职位

职位描述

联系方式

公司信息