Supplier Auditor (QA for Procurement)
美国礼来亚洲公司上海代表处
- 公司规模:500-1000人
- 公司性质:外企代表处
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-04-27
- 工作地点:苏州
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:药品生产/质量管理 供应商管理
职位描述
JD:
1. Auditing:
- Scheduling, preparing, conducting and reporting local and global supplier audits to assess the level of compliance with established standards and current regulations and guidelines.
- Follow-up with suppliers and GMP service providers to ensure corrective actions is taken to satisfactory close audit observations.
- Appropriately escalate any compliance issues.
- Meet the requirements defined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
2. Global Quality - Business Related Responsibilities:
- Assist purchasing, manufacturing and support groups in identifying and managing material suppliers and GMP Service Providers.
- Contribute to the approval process of a new supplier or GMP service provider.
- Provides support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, Regulus.
- Participate or lead the preparation and/or review of documentation used to establish supplier quality requirements, when needed.
- Participate in the preparation of organizational metrics and trending of audit findings, when required.
- Liaison for the sites with suppliers and GMP service providers.
- Participate in the evaluation of third party auditing firms/programs.
- Lead and/or participate in global teams (e.g., Global Auditors Forum).
- Network with other GQAAC business partners on best practices.
- Participate and/or support GQAAC internal inspections or external regulatory inspections.
- Participate and/or lead site self inspections activities, when needed.
3. Personnel Development:
- Provide mentorship to less experienced auditors.
- Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
- Complete required training and qualifications for the roles identified in the Individual Training Plan (ITP).
- Be continually aware of current industry trends and regulatory agency interpretation of requirements.
- Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
- Participate or lead divisional improvement efforts, including Six Sigma projects and departmental/site teams, as assigned.
Requirements:
- Relevant experience(s) (minimum of 5-10 years) with quality, manufacturing at Lilly/Elanco or within the pharmaceutical environment.
- Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
- Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
- Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization and to the suppliers.
- Good analytical/problem-solving skills.
- Proven ability to think and analyze from a process perspective. Project management skills.
- Establish and maintain effective working relationships at all levels internal and external to Lilly/Elanco.
- Deliver constructive feedback to customers while providing a high level of customer service.
- Ability to influence and manage change/conflict.
- Experience working on a global team and sharing knowledge
- Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
- Work independently as well as collaboratively within a global team environment.
- Bachelors Degree (or equivalent work experience) in chemistry, microbiology, physical or biological sciences, engineering or other technical area.
1. Auditing:
- Scheduling, preparing, conducting and reporting local and global supplier audits to assess the level of compliance with established standards and current regulations and guidelines.
- Follow-up with suppliers and GMP service providers to ensure corrective actions is taken to satisfactory close audit observations.
- Appropriately escalate any compliance issues.
- Meet the requirements defined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
2. Global Quality - Business Related Responsibilities:
- Assist purchasing, manufacturing and support groups in identifying and managing material suppliers and GMP Service Providers.
- Contribute to the approval process of a new supplier or GMP service provider.
- Provides support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, Regulus.
- Participate or lead the preparation and/or review of documentation used to establish supplier quality requirements, when needed.
- Participate in the preparation of organizational metrics and trending of audit findings, when required.
- Liaison for the sites with suppliers and GMP service providers.
- Participate in the evaluation of third party auditing firms/programs.
- Lead and/or participate in global teams (e.g., Global Auditors Forum).
- Network with other GQAAC business partners on best practices.
- Participate and/or support GQAAC internal inspections or external regulatory inspections.
- Participate and/or lead site self inspections activities, when needed.
3. Personnel Development:
- Provide mentorship to less experienced auditors.
- Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
- Complete required training and qualifications for the roles identified in the Individual Training Plan (ITP).
- Be continually aware of current industry trends and regulatory agency interpretation of requirements.
- Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
- Participate or lead divisional improvement efforts, including Six Sigma projects and departmental/site teams, as assigned.
Requirements:
- Relevant experience(s) (minimum of 5-10 years) with quality, manufacturing at Lilly/Elanco or within the pharmaceutical environment.
- Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
- Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
- Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization and to the suppliers.
- Good analytical/problem-solving skills.
- Proven ability to think and analyze from a process perspective. Project management skills.
- Establish and maintain effective working relationships at all levels internal and external to Lilly/Elanco.
- Deliver constructive feedback to customers while providing a high level of customer service.
- Ability to influence and manage change/conflict.
- Experience working on a global team and sharing knowledge
- Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
- Work independently as well as collaboratively within a global team environment.
- Bachelors Degree (or equivalent work experience) in chemistry, microbiology, physical or biological sciences, engineering or other technical area.
公司介绍
美国礼来公司(Eli Lilly and Company)是一家全球性的以研发为基础的医药公司,创立于1876年,总部位于美国印地安那州印第安纳波利斯市。2008年礼来全球销售额突破200亿美元,业务遍及全球 143 个国家和地区,雇佣员工四万多人。
礼来于1918年来到中国,将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今,我们在苏州拥有一家独资企业:礼来苏州制药有限公司,30多家办事处,员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。
礼来在中国的许多医药领域居领先地位,如抗感染、中枢神经系统、肿瘤、内分泌等。她的创新药物,不仅挽救病人生命、提高了大众的生活品质,同时也为患者、保健提供者和支付方创造了价值,降低了疾病治疗的成本。
作为全球十大制药企业之一, 礼来始终致力于履行企业社会责任。礼来每年投入巨额资金用于回馈社会。由于礼来在企业社会责任方面的突出贡献,礼来已连续三届荣获《商业周刊》杂志“最慷慨的公司”称号。据《慈善纪事》(Chronicle of Philanthropy)显示,在接受调查的91家美国大型公司中,礼来2006年的捐献数量位居第六。2007年礼来公司慈善捐赠总额约为3.15亿美元,其中包括价值约2.4亿美元的产品捐赠,均用于患者援助计划和国际人道主义事业。2007年公司的捐赠总额大约占公司调整后收入(税前)的6%,再次使礼来成为世界最乐善好施的公司之一。
在中国,礼来也积极推动各项社会公益事业,善尽社会责任,致力成为企业公民的典范。2008年礼来公司在华公益投入总计人民币四千余万元。在南方周末2008中国企业社会责任评选中,礼来中国荣膺“2008世界500强企业慈善公益榜”第3名。
礼来公司有着注重内部培养的用人之道,我们愿意招聘处于职业发展初期的员工加入礼来共同成长并长期服务。当公司出现岗位空缺时,我们能够从内部提拔员工任职或转岗。在礼来中国,我们的管理层有95%来自内部提拔。我们还创建了一种注重员工培训与发展的文化和系统。因此,在业界,我们有“礼来大学”之美誉。我们的培训系统,在职辅导系统,和接班人计划尤其为人们所广为称道。 礼来有着注重绩效和行为并重的文化传统,同时为员工提供全面的薪酬福利保障。 我们以最高道德标准管理我们的业务并在日常工作中要求我们所有的员工。我们相信符合最高道德标准的行为将最终使我们的公司和员工受益。
礼来对中国市场有着中长期的发展战略,我们对这个市场雄心勃勃。从2006开始, 礼来公司启动彩虹计划在内分泌, 抗肿瘤及中枢神经领域进行扩招, 我们的员工队伍已增加了40%,达到了1100多人, 为公司的发展做出来巨大的贡献。从2009年到2013年, 礼来将会进一步加大对中国的投资力度, 礼来中国将进行前所未有的扩张计划。
如果你一直想加入这家有着良好声誉的公司, 现在, 机会之门正在敞开!我们寻求年轻的你, 优秀的你, 自信的你加入我们, 和礼来一起共同成长。无论你是经验丰富的专业人士, 还是胸怀壮志的应届毕业生,相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧,加入我们, 礼来将助你成就梦想!
礼来于1918年来到中国,将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今,我们在苏州拥有一家独资企业:礼来苏州制药有限公司,30多家办事处,员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。
礼来在中国的许多医药领域居领先地位,如抗感染、中枢神经系统、肿瘤、内分泌等。她的创新药物,不仅挽救病人生命、提高了大众的生活品质,同时也为患者、保健提供者和支付方创造了价值,降低了疾病治疗的成本。
作为全球十大制药企业之一, 礼来始终致力于履行企业社会责任。礼来每年投入巨额资金用于回馈社会。由于礼来在企业社会责任方面的突出贡献,礼来已连续三届荣获《商业周刊》杂志“最慷慨的公司”称号。据《慈善纪事》(Chronicle of Philanthropy)显示,在接受调查的91家美国大型公司中,礼来2006年的捐献数量位居第六。2007年礼来公司慈善捐赠总额约为3.15亿美元,其中包括价值约2.4亿美元的产品捐赠,均用于患者援助计划和国际人道主义事业。2007年公司的捐赠总额大约占公司调整后收入(税前)的6%,再次使礼来成为世界最乐善好施的公司之一。
在中国,礼来也积极推动各项社会公益事业,善尽社会责任,致力成为企业公民的典范。2008年礼来公司在华公益投入总计人民币四千余万元。在南方周末2008中国企业社会责任评选中,礼来中国荣膺“2008世界500强企业慈善公益榜”第3名。
礼来公司有着注重内部培养的用人之道,我们愿意招聘处于职业发展初期的员工加入礼来共同成长并长期服务。当公司出现岗位空缺时,我们能够从内部提拔员工任职或转岗。在礼来中国,我们的管理层有95%来自内部提拔。我们还创建了一种注重员工培训与发展的文化和系统。因此,在业界,我们有“礼来大学”之美誉。我们的培训系统,在职辅导系统,和接班人计划尤其为人们所广为称道。 礼来有着注重绩效和行为并重的文化传统,同时为员工提供全面的薪酬福利保障。 我们以最高道德标准管理我们的业务并在日常工作中要求我们所有的员工。我们相信符合最高道德标准的行为将最终使我们的公司和员工受益。
礼来对中国市场有着中长期的发展战略,我们对这个市场雄心勃勃。从2006开始, 礼来公司启动彩虹计划在内分泌, 抗肿瘤及中枢神经领域进行扩招, 我们的员工队伍已增加了40%,达到了1100多人, 为公司的发展做出来巨大的贡献。从2009年到2013年, 礼来将会进一步加大对中国的投资力度, 礼来中国将进行前所未有的扩张计划。
如果你一直想加入这家有着良好声誉的公司, 现在, 机会之门正在敞开!我们寻求年轻的你, 优秀的你, 自信的你加入我们, 和礼来一起共同成长。无论你是经验丰富的专业人士, 还是胸怀壮志的应届毕业生,相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧,加入我们, 礼来将助你成就梦想!
联系方式
- 公司网站:http://www.lillychina.com
- 公司地址:上海市湖滨路222号企业天地1号楼21层
- 邮政编码:200021